Compliance and persistence to oral bisphosphonate therapy following initiation within a secondary fracture prevention program: a randomised controlled trial of specialist vs. non-specialist management Change in Bone Mineral Density Is an Indicator of Treatment-Related Antifracture Effect in Routine Clinical Practice Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis Evaluation of Three Population-Based Strategies for Fracture Prevention: Results of the Osteoporosis Population-Based Risk Assessment (OPRA) Trial Low acceptance of treatment in the elderly for the secondary prevention of osteoporotic fracture in the acute rehabilitation setting A Randomized Educational Intervention Trial to Determine the Effect of Online Education on the Quality of Resident-Delivered Care. Relative Effectiveness of Osteoporosis Drugs for Preventing Nonvertebral Fracture Relationship between compliance and persistence with osteoporosis medications and fracture risk in primary health care in France: a retrospective case-control analysis. The Effectiveness of Pharmacist-Provided Telephonic Medication Therapy Management on Emergency Department Utilization in Home Health Patients Raloxifene reduces risk of vertebral fractures [corrected] in postmenopausal women regardless of prior hormone therapy. Acceptance of Hip Protectors for Hip Fracture Prevention in Nursing Homes
 Use of Calcium Supplements, Vitamin D Supplements and Specific Osteoporosis Drugs Among French Women Aged 75–85 Years: Patterns of Use and Associated Factors Effectiveness of a falls-and-fracture nurse coordinator to reduce falls: a randomized, controlled trial of at-risk older adults. A pilot randomized controlled trial of a decision aid with tailored fracture risk tool delivered via a patient portal Evaluating the cost-effectiveness of fall prevention programs that reduce fall-related hip fractures in older adults. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. Effects of medication reviews performed by a physician on treatment with fracture-preventing and fall-risk-increasing drugs in older adults with hip fracture-a randomized controlled study. Home exercise to improve strength and walking velocity after hip fracture: a randomized controlled trial. Cost-effectiveness of hip protectors in frail institutionalized elderly Hypovitaminosis D and 'functional hypoparathyroidism'-the NoNoF (Nottingham Neck of Femur) study. Evaluation of a Nationwide Pharmacist-Led Phone Outreach Program to Improve Osteoporosis Management in Older Women with Recently Sustained Fractures. Osteoporosis telephonic intervention to improve medication regimen adherence: a large, pragmatic, randomized controlled trial. Improvements in 1-Year Cardiovascular Clinical Outcomes Associated with a Hospital-Based Discharge Medication Program
Summary Following initiation of oral bisphosphonate therapy through a secondary fracture prevention program , 2-year treatment compliance and persistence remained high and were similar in patients r and omised to follow-up by either the program or primary care physician . Thus , community-based and specialist management are equally effective in supporting compliance and persistence with anti-osteoporotic treatments . Introduction The purpose of this study was to determine whether management by a secondary fracture prevention ( SFP ) program ( aka “ fracture liaison service ” ) results in better compliance and persistence to oral bisphosphonate therapy than follow-up by the primary care physician , after initiation within an SFP program . Methods This prospect i ve RCT included 102 patients with incident osteoporotic fractures referred to a SFP program in Sydney , Australia . Following oral bisphosphonate therapy initiation , patients were r and omised to either 6-monthly follow-up with the SFP program ( group A ) or referral to their primary care physician with a single SFP program visit at 24 months ( group B ) . Compliance and persistence to treatment were measured using pharmaceutical cl aims data . Predictors of compliance and persistence and associations between compliance and persistence , and changes in bone mineral density ( BMD ) or bone resorption marker , urinary deoxypyridinoline over 24 months were analysed . Results The median medication possession ratio at 24 months was 0.78 ( IQR , 0.50–0.93 ) in group A and 0.79 ( IQR , 0.48–0.96 ) in group B ( p = 0.68 ) . Persistence at 24 months was also similar in both groups ( 64 vs. 61 % , respectively ; p = 0.75 ) . After adjusting for confounders , patients in group A were not more likely to be compliant ( OR , 1.06 ; 95 % CI , 0.46–2.47 ) or persistent ( HR , 0.83 ; 95 % CI , 0.27–1.67 ) than those r and omised to group B. Time-based changes in BMD or bone turnover were not associated with compliance or persistence . Conclusion Compliance and persistence to oral bisphosphonate therapy remain high amongst patients initiated within an SFP program , with community-based and SFP program management being equally effective in maintaining therapeutic compliance and persistence over 2 years . These results indicate that one of the main functions of an SFP program may be the initiation of therapy rather than continuous patient monitoring Osteoporosis-related fractures are common and impose a large societal burden in terms of human and economic costs ( 1 ) . In the absence of a typical low-trauma fracture ( for example , vertebral compression fracture ) ( 2 ) , the diagnosis of osteoporosis is usually based on finding low bone mineral density ( BMD ) from dual-energy x-ray absorptiometry ( DXA ) ( 3 , 4 ) . Screening with DXA is recommended for women aged 65 years or older and in younger women with elevated fracture risk ( 5 ) . In appropriately selected women , approved treatments can reduce fracture risk in primary and secondary prevention setting s ( 6 , 7 ) . The role for repeated BMD testing  after initial evaluation is uncertain because prospect i ve studies have not shown that repeated BMD measurements or changes in BMD were more predictive of subsequent fractures than the baseline measurement ( 5 , 8) . The practice of repeated  BMD testing during pharmacotherapy also remains controversial ( 9 , 10 ) . Group-level clinical trial data suggest that greater increases in BMD are associated with greater fracture risk reduction ( 11 , 12 ) , but this may be more difficult to show in individuals as measurement error is typically 3 % to 5 % ( 1315 ) . In clinical trials in which good patients are selected for participation and their adherence is closely monitored , treatment failuredefined as detectable BMD lossis uncommon , particularly when the patients are receiving bisphosphonates , which is the most widely used class of drugs for osteoporosis ( 16 ) . Results from clinical trials are not always applicable to clinical practice in which patients are lost to follow-up , adherence and persistence with medications are difficult to monitor , and patients often have underlying conditions that would exclude many from trial participation . We used population -based registries from Manitoba , Canada , to assess the effectiveness of repeated  BMD testing in routine clinical practice as a predictor of treatment-related fracture risk reduction in women initiating treatment . Methods Patient Population In Manitoba , Canada ( population , 1.2 million persons ) , health services are provided to virtually all residents through a public health care system . Since 1997 , DXA testing has been managed as an integrated program ( the Manitoba Bone Density Program ) ; criteria for baseline testing include screening women at age 65 years and younger women with additional risk factors ( 17 ) . Consistent with national guidelines , the program 's recommended interval for initial follow-up is 3 years for most patients , 1 year for those receiving systemic glucocorticoid therapy or aromatase inhibitors , and at least 5 years for those previously reported as low-risk ( 18 ) . The program maintains a data base of all DXA results that can be linked with other population -based computerized health data bases through an anonymous personal identifier . The DXA data base has completeness and accuracy in excess of 99 % ( 19 ) . From this data base , we identified all women aged 40 years or older with baseline DXA measurements of the hip or lumbar spine obtained from 1 of the program 's cross-calibrated primary DXA instruments ( Prodigy ; GE Healthcare Lunar ) after 1 April 1998 . We then identified those with a follow-up DXA examination before 31 March 2013 ( minimum interval of 1 year ) for assessment of change in BMD in at least 1 measurement site ( total hip , femoral neck , or lumbar spine ) . Using linkage to the province-wide retail pharmacy network ( 20 ) , we identified women not receiving osteoporosis treatment during the year before baseline DXA testing ( defined as no pharmacy-dispensed bisphosphonate , calcitonin , systemic estrogen product , raloxifene , or teriparatide ) who initiated 1 of these same osteoporosis treatments between the first and second DXA scans ( defined as 1 or more prescription dispensations ) . Analyses did not consider subsequent medication switching . The study was approved by the Health Research Ethics Board of the University of Manitoba . BMD Measurements Lumbar spine and hip DXA scans were performed and analyzed in accordance with manufacturer recommendations . Femoral neck and total hip T-scores ( number of SDs above or below the mean BMD for young adults ) were calculated from NHANES III ( Third National Health and Nutrition Examination Survey ) reference values for white women ( 21 ) ; lumbar spine ( L1 to L4 ) T-scores were based on the manufacturer 's reference values for white women ( 22 ) . The program 's quality assurance is under strict supervision by a medical physicist ( 17 ) . The instruments used for this study exhibited stable long-term performance ( coefficient of variation , < 0.5 % ) . All reporting physicians and supervising technologists are required to maintain DXA certification with the International Society for Clinical Densitometry . The absolute BMD difference ( measured in g/cm2 ) between the 2 DXA tests was compared with 95 % least-significant change ( LSC ) values for assessment of change using accepted methods , where LSC is the least amount of change in BMD that can be considered statistically significant ( 2325 ) . The BMD measurement error of the Manitoba Bone Density Program used for computing the LSC is derived from more than 400 DXA scan pairs ( most performed on different days but within 28 days by different technologists ) . We have previously reported that this approach ( rather than same-day repositioning with the same technologist ) is more representative of measurement error encountered during clinical monitoring ( 26 ) . From these scan pairs , we obtained the following 95 % LSC values , which are within acceptable ranges ( 25 ) : total hip , 0.030 g/cm2 ; lumbar spine , 0.050 g/cm2 ; and femoral neck , 0.055 g/cm2 . An observed absolute difference less than these values would be considered to be within the range of measurement error ( stable ) , whereas an increase or decrease exceeding these values would be outside the range of measurement error ( detectable increase or decrease in BMD , respectively ) . The use of the absolute difference for BMD monitoring follows International Society for Clinical Densitometry recommendations and avoids errors that can arise when change is expressed as a percentage ( 27 , 28 ) . Baseline Fracture Probability Calculations The 10-year probability of the risk for major osteoporotic fracture was calculated by using the Canadian version of the World Health Organization Fracture Risk Assessment Tool ( FRAX ) , version 3.7 ( FRAX Desktop Multi-Patient Entry ) ( 29 , 30 ) . Age , body mass index , femoral neck BMD , and other data required for calculating fracture probability with FRAX were assessed through a combination of hospital discharge abstract s ( diagnoses and procedures coded using the International Classification of Diseases , Ninth Revision , Clinical Modification , before 2004 and International Statistical Classification of Diseases and Related Health Problems , 10th Revision , Canada thereafter ) , physician billing cl aims ( coded using International Classification of Diseases , Ninth Revision , Clinical Modification ) , and information collected directly from patients at the time of DXA scanning as previously described ( Appendix Table ) ( 31 ) . The Canadian FRAX was calibrated by using nationwide hip fracture data ( 30 ) . Predictions agreed closely with observed fracture risk in our population ( 31 , 32 ) . Appendix Table . Study Population Baseline Characteristics , by Variables Used in Fracture Probability Assessment and Incident Fracture Outcomes * Fractures Outcomes Records from Manitoba Health were assessed for the presence of incident nontraumatic hip , clinical vertebral , forearm , and humerus fracture diagnostic codes ( collectively design ated as major osteoporotic fractures ) using previously vali date d algorithms ( 33 , 34 ) . Fractures that were not associated with trauma codes were assessed through a combination of hospital discharge abstract s and physician billing cl aims . We required that hip and forearm fracture codes be associated with site-specific fracture reduction , fixation , or casting codes to enhance specificity for an acute fracture event . To minimize potential misclassification of prior incident fractures , we conservatively required that there be no hospitalization or physician visit for the same fracture type in the 6 months preceding an incident fracture diagnosis . Statistical Analysis Cumulative fracture incidence after the first DXA scan ( index date ) was studied using survival analysis . Observations were censored for death , migration out of province , or end of follow-up ( 31 March 2013 ) . Our primary analysis examined change in total hip BMD between DXA scans , which was the site with the smallest measurement error ; these scans were categorized as stable ( referent ) , detectable decrease , or detectable increase . Cumulative incidence curves , along with point estimates and 95 % CIs at 5 and 10 years , were directly adjusted for baseline fracture probability ( 35 ) . Average absolute differences in cumulative fracture risk were compared based on change in BMD ( detectable decrease or increase vs. stable BMD ) , and 95 % CIs were estimated . Analyses were conducted using SAS , version 9.3 ( SAS Institute ) . We did a series of secondary sensitivity analyses to test the robustness of our findings and explore potential interactions . First , we examined hip fractures as the outcome of interest given their large implication s on morbidity , mortality , and cost compared with other fractures . Second , we constructed separate models for change in femoral neck and lumbar spine BMD . Finally , we explored potential interactions in multiplicative Cox proportional hazards models stratified according to age ( 40 to 64 , 65 to 74 , and 75 years ) ; baseline BMD ( osteoporotic vs. nonosteoporotic T-scores ) ; BMD testing interval ( 1 to 2.9 , 3 to 5 , and > 5 years ) ; and medication possession ratio ( < 0.5 , 0.50 to 0.79 , and 0.80 ) , which is an adherence measure calculated as the total days of medication supplied between the BMD tests divided by the testing interval . In the Cox regression models , we Objectives A history of prior fracture is one of the strongest predictors of a future fragility fracture . In FREEDOM , denosumab significantly reduced the risk of new vertebral , non-vertebral , and hip fractures . We carried out a post-hoc analysis of FREEDOM to characterize the efficacy of denosumab in preventing secondary fragility fractures in subjects with a prior fracture . Methods A total of 7808 women aged 60–90 years with a bone mineral density T-score of less than − 2.5 but not less than − 4.0 at either the lumbar spine or total hip were r and omized to subcutaneous denosumab 60 mg or placebo every 6 months for 36 months . The anti-fracture efficacy of denosumab was analyzed by prior fracture status , to assess secondary fragility fracture , and by subject age , prior fracture site and history of prior osteoporosis medication use . Results A prior fragility fracture was reported for 45 % of the overall study population . Compared with placebo , denosumab significantly reduced the risk of a secondary fragility fracture by 39 % ( incidence , 17.3 % vs. 10.5 % ; p < 0.0001 ) . Similar results were observed regardless of age or prior fracture site . In the overall population , denosumab significantly reduced the risk of a fragility fracture by 40 % ( 13.3 % vs. 8.0 % ; p < 0.0001 ) , with similar results observed regardless of history of prior osteoporotic medication use . Conclusions Denosumab  reduced the risk of fragility fractures to a similar degree in all risk subgroups examined , including those with prior fragility fractures . Identifying and treating high-risk individuals could help to close the current care gap in secondary fracture prevention Background : The integration of bone density testing into well- design ed fracture prevention programs that can be applied in population s has not been studied . Objectives : We sought to compare the outcomes of 3 strategies for allocating bone density testing within an HMO-based fracture prevention program . Research Design : Women were r and omly sample d and allocated to one of 3 groups : ( 1 ) a universal group , in which all were offered bone mineral density ( BMD ) testing ( 1986 contacted ; 415 participated ) ; 2 ) the SCORE group , in which women scoring ≥ 7 on the SCORE question naire were invited for BMD testing ( 1940 contacted ; 576 participated ) ; and ( 3 ) the Study of Osteoporotic Fracture (SOF)-based group , in which women with ≥ 5 hip fracture risk factors were invited for BMD testing ( 5342 contacted ; 2176 participated ) . Subjects : Women aged 60–80 not taking hormone therapy or osteoporosis medication were included . Measures : Outcomes ascertained during 33 months of follow-up in all women contacted included initiation of osteoporosis treatment and hip and total fracture rates . Outcomes evaluated among all participants included changes in fracture risk factors , osteoporosis knowledge , and satisfaction with the program . Results : Osteoporosis treatment rates did not differ among all women contacted but were slightly higher among trial participants in the universal and SCORE groups ( 21.1 % and 20.2 % , respectively ; versus 16.7 % in the SOF-based group ( P value versus universal = 0.04 ) . Among all women contacted , fracture rates were lowest in the universal group ( 74.11/1000 ) and differed significantly compared with the SCORE ( 99.44/1000 ; P = 0.009 ) and SOF-based groups ( 91.77/1000;P = 0.02 ) . Knowledge about osteoporosis risk factors was highest in the universal group and lowest in the SOF-based group ( P < 0.01 ) . Conclusions : The degree to which BMD testing was offered to women in a fracture prevention program significantly affected total fracture rates , change in some fracture risk factors , and knowledge about risk factors Background and aims : Given the high risk of subsequent fracture among elderly persons with fracture , it is important to initiate secondary treatment for osteoporosis . Acute rehabilitation centers may offer a unique opportunity to introduce treatment . Therefore , we evaluated willingness-to-participate and compliance with evidence -based interventions for the secondary prevention of  osteoporotic fracture in a non-r and omized study conducted in the acute rehabilitation setting . We also described differences in baseline characteristics between study participants and non- participants . Methods : All consecutive , community-dwelling admissions to an acute rehabilitation unit ( Boston , MA ) with the diagnosis of fracture were screened for enrollment . Eligible subjects were offered a free , 6-month supply of alendronate/cholecalciferol ( 70 mg/2800 IU weekly ) , calcium and vitamin D supplements , and fall prevention strategies . Six-month compliance ( ≥75 % consumption of medication or supplement ) with the interventions was determined at a home visit . Results : Among 62 eligible subjects , 25 agreed to participate . Non- participants were older than participants ( 86 vs 80 yrs , p<0.01 ) . There was no significant difference between other characteristics of participants and non- participants including sex , weight , type of fracture , cognitive status , and functional status . The most common reason for non-participation was reluctance to take another medication . Among participants , only 52 % were compliant with alendronate and 58 % were compliant with calcium and vitamin D supplementation at 6 months . Conclusions : Willingness-to-participate and compliance with secondary prevention strategies for osteoporosis was low in the acute rehabilitation setting , even when medications were provided free of cost . Educating individuals with fracture and their families on the consequences and treatment of osteoporosis may help to decrease the risk of sustaining a second fracture by accepting secondary preventive measures BACKGROUND There is limited research on whether online formative self- assessment and learning can change the behavior of medical professionals . OBJECTIVE We sought to determine if an adaptive longitudinal online curriculum in bone health would improve resident physicians ' knowledge , and change their behavior regarding prevention of fragility fractures in women . METHODS We used a r and omized control trial design in which 50 internal medicine resident physicians at a large academic practice were r and omized to either receive a  st and ard curriculum in bone health care alone , or to receive it augmented with an adaptive , longitudinal , online formative self- assessment curriculum delivered via multiple-choice questions . Outcomes were assessed 10 months after the start of the intervention . Knowledge outcomes were measured by a multiple-choice question examination . Clinical outcomes were measured by chart review , including bone density screening rate , calculation of the fracture risk assessment tool ( FRAX ) score , and rate of appropriate bisphosphonate prescription . RESULTS Compared to the control group , residents participating in the intervention had higher scores on the knowledge test at the end of the study . Bone density screening rates and appropriate use of bisphosphonates were significantly higher in the intervention group compared with the control group . FRAX score reporting did not differ between the groups . CONCLUSIONS Residents participating in a novel adaptive online curriculum outperformed peers in knowledge of fragility fracture prevention and care practice s to prevent fracture . Online adaptive education can change behavior to improve patient care Context Few studies have evaluated the relative effectiveness of drug therapies for osteoporosis . Contribution This study compared nonvertebral fractures that occurred within 1 year of initiating osteoporosis pharmacotherapy among 43135 enrollees in 2 statewide pharmaceutical benefit programs . Differences in fracture risk between adults prescribed risedronate or raloxifene and those prescribed  alendronate  were small . Fracture risk seemed to be higher with calcitonin than alendronate . Caution Wide confidence bounds around risk estimates did not rule out potentially important differences between some agents . No adherence data were available , and the ability to account for confounders was limited . Implication There probably is no single clearly superior drug therapy for osteoporosis . The Editors Osteoporosis is characterized by decreased bone mass and deterioration of bone tissue , result ing in reduced bone strength and increased fracture risk ( 1 , 2 ) . Approved therapies for osteoporosis include bisphosphonates , calcitonin , raloxifene , and teriparatide . Findings from r and omized , controlled , head-to-head trials show that women who received alendronate have greater gains in bone mineral density and greater reductions in bone turnover markers within 12 and 24 months of initiation than those who received risedronate ( 3 , 4 ) or raloxifene ( 57 ) . Although bone mineral density is a strong predictor of fracture ( 8) , differences in these surrogate markers may not translate into appreciable differences in fracture risk ( 911 ) . Results from observational studies suggest that risedronate may reduce the risk for nonvertebral fracture ( clavicle , hip , humerus , leg , pelvis , and wrist ) within 12 months more effectively than alendronate or nasal calcitonin ( 12 , 13 ) . To our knowledge , no studies have compared the relative effectiveness of raloxifene versus bisphosphonates or calcitonin in reducing fracture risk . Further comparative effectiveness studies may help to clarify the relative effectiveness of osteoporosis treatments ( 14 ) . We completed a population -based study of new recipients of oral bisphosphonates ( alendronate or risedronate ) , nasal calcitonin , and raloxifene to compare the relative effectiveness of these agents in reducing nonvertebral fracture risk . Methods Study Cohort The study population comprised Medicare beneficiaries enrolled in 2 statewide pharmaceutical benefit plans : the New Jersey Pharmaceutical Assistance to the Aged and Disabled program and the Pennsylvania Pharmaceutical Assistance Contract for the Elderly . These programs provide drug coverage without restriction for low-income residents age 65 years or older with minimal copayment . Our cohort consisted of new recipients ( no use of any of these agents in the previous year ) of oral bisphosphonates ( alendronate , 10 mg or 70 mg , or risedronate , 5 mg or 35 mg ) , nasal calcitonin , or raloxifene  between 1 April 2000 and 30 June 2005 ( Figure 1 ) . To ensure complete plan coverage , study eligibility was limited to patients with 1 or more cl aims in both Medicare and their state pharmaceutical assistance plan in each of the three 6-month intervals preceding the index prescription . We excluded nursing home residents ( for whom prescription data may not be complete ) , patients with a Medicare cl aim for Paget disease ( International Classification of Diseases , Ninth Revision , Clinical Modification code 731.0 ) , and patients with pharmacy cl aims indicating receipt of any bisphosphonate or teriparatide in the year before treatment initiation . Our data included all Medicare beneficiaries from the 2 plans that met eligibility criteria ; we did not do formal sample size calculations . We restricted inclusion to the period when all drugs were available : that is , 1 April 2000 ( risedronate received U.S. Food and Drug Administration approval in April 2000 ) . At the time of analysis , we had complete Medicare data from 1 April 2000 to 31 December 2003 for New Jersey and from 1 April 2000 to 31 December 2005 for Pennsylvania . Figure 1 . Study flow diagram . Osteoporosis drugs were oral bisphosphonates ( alendronate , 10 mg or 70 mg ; risedronate , 5 mg or 35 mg ) , nasal calcitonin , or raloxifene . * May meet > 1 exclusion criterion . Outcomes Our primary outcome of interest was nonvertebral fracture within 12 months of treatment initiation . We defined nonvertebral fracture as a fracture of the hip , humerus , or radius or ulna by using previously vali date d criteria requiring diagnostic and procedural codes from Medicare cl aims ( 15 ) . When medical records are used as the reference st and ard , the estimated sensitivity of each outcome is at least 90 % ( 15 ) . Secondary outcomes included nonvertebral fractures within 6 and 24 months of treatment initiation and hip fracture within 6 , 12 , and 24 months of treatment initiation . Covariates Patient demographic characteristics were determined at treatment initiation and other variables by medical and pharmacy cl aims within the year before treatment initiation . We considered covariates that were plausibly related to our fracture outcomes ( 16 ) : demographic characteristics ( age , sex , race ) , osteoporosis-related factors ( such as diagnosis of osteoporosis , fracture history ) , relevant comorbid conditions ( such as comorbidity score [ 17 , 18 ] ; diabetes mellitus ; history of falls , syncope , and gait abnormalities ; cancer ; rheumatoid arthritis ) , drug use ( such as antiepileptics , -blockers , benzodiazepines , glucocorticoids , hormone therapy , selective serotonin reuptake inhibitors , thiazide diuretics , number of drugs ) , and previous hospitalization . We also included calendar time ( month and year ) of the index prescription to adjust for potential secular trends in prescribing . Appendix Table 1 lists all variables , definitions , and coding . If a record of a specific diagnosis , procedure , or prescription was lacking , patients were coded as not having these characteristics . As a result of this coding rule , there were no participants for whom exposure , confounder , or outcome information was missing . However , race was unknown in 41 patients . These 41 missing data points were recoded as Caucasian . Appendix Table 1 . Definition and Coding of Variables Included in Multinomial Logistic Regression Model Used to Create Propensity Scores Statistical Analysis We calculated fracture rates among recipients of each drug within 6 , 12 , and 24 months of treatment initiation . We used KaplanMeier methods to plot cumulative fracture incidence and Cox proportional hazard models to compare fracture rates between agents . In our primary analysis , we considered a patient exposed to drug throughout follow-up by censoring only at date of death or end of follow-up ( hereafter referred to as intent-to-treat analysis , an analogue of intention-to-treat analysis ) . We tested proportional hazard assumptions by using interaction terms between exposures and time and found no violations for the primary analysis of 12-month follow-up . However , we observed a violation result ing in an attenuated effect for raloxifene over 24 months . This observation is expected when an intent-to-treat scenario is assumed because adherence to osteoporosis pharmacotherapy is suboptimal ( 19 , 20 ) . Similar attenuation of effects was also observed when hip fracture was the outcome . We developed propensity scores for each drug by using multinomial logistic regression ( 21 ) . Alendronate , the most commonly prescribed osteoporosis treatment , was selected as the reference category . To account for baseline differences between New Jersey and Pennsylvania , we derived state-specific propensity scores and stratified all adjusted Cox proportional hazard models by state . Propensity score quintiles for risedronate , calcitonin , and raloxifene were included as 12 dummy variables ( 4 for each drug ) to adjust for confounding ( 2124 ) . We summarized the balance achieved within state-specific propensity score quintiles into descriptive tables and examined the magnitude of difference for each covariate within each propensity score quintile . Preliminary examination suggested residual imbalance within some quintiles ( Appendix Tables 2 and 3 ) . For example , within the lowest propensity score quintile for receipt of raloxifene in New Jersey ( Appendix Table 2 ) , 76 % of patients who received alendronate and 87 % of patients who received raloxifene had a background prevalence of osteoporosis . Therefore , we included age groups , fracture history , race , and diagnosis of osteoporosis , in addition to propensity score quintiles , in our adjusted regression models . Analyses were performed with SAS software , version 9.1 ( SAS Institute , Cary , North Carolina ) . Appendix Table 2 . Propensity Score Quintiles : New Jersey * Appendix Table 3 . Propensity Score Quintiles : Pennsylvania * We used sensitivity analysis to examine the robustness of our findings . First , we examined outcomes assuming an on-treatment scenario . We censored patients on the first day of switching agents , losing drug plan eligibility , entering a nursing home , or discontinuing drug therapy ( last date covered by drug plus 15 days , allowing for 30-day gaps between prescriptions ) , on the day of death , or at the end of follow-up ( 12 months , 31 December 2003 [ New Jersey ] , or 31 December 2005 [ Pennsylvania ] ) . Second , we extended the days that patients received therapy in our on-treatment scenario to the last date covered by drug plus 90 days . Third , we examined several different subgroups : history of any fracture ( International Classification of Diseases , Ninth Revision , Clinical Modification codes 733.1x and 800.xx through 829.xx ) within the year before treatment initiation , no fracture history , at least 2 consecutive prescriptions of their index drug , no known history of malignant neoplasm , osteoporosis diagnosis , no diagnosis of osteoporosis , and women with no previous hormone therapy . Fourth , given that the main risk factors for fracture measurable in our data set are previous fracture and age , we compared fracture rates stratified by BACKGROUND Nonadherence to treatment is an important determinant of long-term outcomes in women with osteoporosis . OBJECTIVES This study was conducted to investigate the association between adherence and osteoporotic fracture risk and to identify optimal thresholds for good compliance and persistence . A secondary objective was to perform a preliminary evaluation of the cost consequences of adherence . METHOD This was a retrospective case-control analysis . Data were derived from the Thales prescription data base , which contains information on > 1.6 million patients in the primary health care setting in France . Cases were women aged > or=50 years who had an osteoporosis-related fracture in 2006 . For each case , 5 matched controls were r and omly selected . Both compliance and persistence aspects of treatment adherence were examined . Compliance was estimated based on the medication possession ratio ( MPR ) . Persistence was calculated as the time from the initial filling of a prescription for osteoporosis medication until its discontinuation . RESULTS The mean ( SD ) MPR was lower in cases compared with controls ( 58.8 % [ 34.7 % ] vs 72.1 % [ 28.8 % ] , respectively ; P < 0.001 ) . Cases were more likely than controls to discontinue osteoporosis treatment ( 50.0 % vs 25.3 % ; P < 0.001 ) , yielding a significantly lower proportion of patients who were still persistent at 1 year ( 34.1 % vs 40.9 % ; P < 0.001 ) . MPR was the best predictor of fracture risk , with an area under the receiver-operating-characteristic curve that was higher than that for persistence ( 0.59 vs 0.55 ) . The optimal MPR threshold for predicting fracture risk was > or=68.0 % . Compared with less-compliant women , women who achieved this threshold had a 51 % reduction in fracture risk . The difference in annual drug expenditure between women achieving this threshold and those who did not was approximately euro300 . The optimal threshold for persistence with therapy was at least 6 months . Attaining this threshold was associated with a 28 % reduction in fracture risk compared with less-persistent women . CONCLUSIONS In this study , better treatment adherence was associated with a greater reduction in fracture risk . Compliance appeared to predict fracture risk better than did persistence Background : Preventable emergency department ( ED ) use may be targeted with interventions for improving the medication use process , as medication misadventures and nonadherence frequently cause preventable ED utilization . One intervention that could prevent ED visits is medication therapy management ( MTM ) . Objective : To evaluate the effectiveness of a telephonic MTM service on reducing ED utilization within a Medicare-insured home health population . Methods : This was a secondary analysis of data from a cluster-r and omized controlled trial examining hospitalizations among Medicare-insured patients within 40 r and omly selected , geographically diverse , home health centers . The intervention consisted of an initial telephonic medication reconciliation with a pharmacy technician , a telephonic pharmacist-provided medication review , and follow-up pharmacist phone calls . The primary outcome of this analysis was 60-day all-cause ED utilization . Patients  ’ baseline risk of ED utilization was calculated , and patients were stratified into quartiles based on their baseline risk of ED utilization . Adjusted odd ratios of ED utilization were calculated . Results : Data from 656 patients ( intervention n = 297 , usual care n = 359 ) were available for this study . Overall , the MTM intervention was not associated with 60-day ED use , as 24.4 % of intervention patients and 25.1 % of usual care patients utilized the ED ( adjusted odds ratio = 1.11 ; 95 % confidence interval = 0.79 - 1.57 ) . However , there was lower ED utilization among patients in the lowest risk-quartile ( adjusted odds ratio = 2.52 ; 95 % confidence interval = 1.15 - 5.49 ; P = .02 ) . Conclusion : This pharmacist-delivered telephonic MTM program did not decrease ED utilization overall in a Medicare-insured home health population , but may further reduce the risk of ED utilization among patients who are at lower risk of utilization OBJECTIVE We examined whether past use of hormone therapy influences the effects of raloxifene on the risk of new vertebral fracture , cardiovascular events , or breast cancer . STUDY DESIGN The Multiple Outcomes of Raloxifene Evaluation ( MORE ) trial examined vertebral fracture incidence as the primary endpoint , breast cancer incidence as a secondary endpoint . Cardiovascular events were collected as secondary safety endpoints . POPULATION The MORE trial enrolled 7705 postmenopausal women . Of the 7682 women who reported their previous HT use status , 29 % used HT before screening . OUTCOMES MEASURED Separate logistic regression models analyzed the relationships between prior HT use and the risk of vertebral fracture , cardiovascular events , or breast cancer . Interaction terms with P<.10 were considered to be statistically significant . Confidence intervals for relative risks ( RR ) were calculated using the Mantel-Haenszel method . RESULTS Raloxifene 60 mg/d , the clinical ly approved dose for osteoporosis prevention and treatment , reduced the risk of vertebral fractures by 54 % ( RR=0.46 ) and 29 % ( RR=0.71 ) in women with and without prior HT use , respectively ( interaction P=.05 ) . A lower incidence of invasive breast cancer in women with prior HT use ( RR=0.23 ) and in women without prior HT use [ RR=0.31 ; interaction P=.60 ] was observed in women receiving raloxifene ( pooled doses ) . Irrespective of prior HT use , women treated with raloxifene ( pooled doses ) had no change in incidence of cardiovascular events ( interaction P=.56 ) . CONCLUSIONS The risk of vertebral fractures was lower in women treated with raloxifene , regardless of prior HT use , but there was a suggestion that the effect was greater in women who had used HT . Women r and omized to receive raloxifene exhibited a decreased incidence of invasive breast cancer , compared with women receiving placebo . No change occurred in the incidence of cardiovascular events , regardless of prior HT use In order to prevent hip fractures  548 fall-prone senior citizens living in 20 nursing homes participated in a r and omized controlled trial of hip protectors .  One hundred and sixty-four were r and omly selected into the control group and 384 into the intervention group . Of the patients in the intervention group 138 ( 35.9 % ) wore the  protector  throughout the whole 10 months of the study ’s duration , 124 ( 32.3 % ) quit wearing the protectors after an initial wearing period and 122 ( 31.8 % ) refused to wear them at all . The regular wearers had the protector on during an average of roughly 12 hours a day , so they were protected for 50 % of their exposure time ( including at night ) . Fifty-nine percent of the drop-outs stopped wearing the protectors in the first two study months , mostly for non-medical reasons . Calculation by a forecasting model showed that those senior citizens who were initially prepared to wear the protector tended to be those who were physically restricted Background Despite the availability of effective preventive and curative medications for osteoporosis , and guidelines for its diagnosis and management , few individuals are treated for osteoporosis , even among those who have already had a fracture . Objectives Our objective was to describe the patterns of use of medication for osteoporosis , i.e. , calcium supplements , vitamin D supplements , and specific anti-osteoporotic drugs , such as bisphosphonates , in a large sample of French older women living at home , and to identify individual factors associated with use of these medications overall and in two specific clinical situations . Methods Cross-sectional analysis of data from 4,221 women aged 75–85 years who participated in a balance and mobility examination as part of the screening procedure for the Ossébo study , a r and omized controlled trial testing the effectiveness of exercise for the prevention of fall-related injuries .  Electoral rolls  were used to invite women in 16 towns to participate ( participation rate 10.3 % ) . Information collected through question naires included current medication use and , in particular , use of osteoporosis medications ( specific osteoporosis drugs , calcium and vitamin D supplementation ) in the past 6 months , and history of fracture since the age of 50 , including fracture locations . Fractures were categorized in three groups : no fracture , major osteoporotic fracture ( hip , humerus , wrist , pelvis , and vertebra ) , and other fracture . Results Nearly 48 % of the participants reported they did not take calcium or vitamin D supplements or any specific  osteoporosis drugs  . Of the 2,133 women who reported using osteoporosis medication , 85 % used  vitamin D supplements ( 25 % as the sole medication against this disease ) , 59 % calcium supplements , and 42 % a specific anti-osteoporotic drug ( 75 % of them combining it with vitamin D supplementation ) . The use of any osteoporosis medication was significantly associated ( p < 0.001 ) with a history of a major osteoporotic fracture , lower weight , dual-energy X-ray absorptiometry ( DXA ) bone-density measurement in the past 5 years , a cancer-screening examination in the past 5 years , and a positive attitude toward medication use in general . Living alone was associated with a lower likelihood of using a specific anti-osteoporotic drug  , and a higher education level was associated with a higher likelihood of vitamin D supplementation . Of the 1,553 women who had already had a major osteoporotic fracture , one-third ( 34.8 % ) were not taking any osteoporosis medication . In this subgroup , use of this medication was associated with the same factors as in the overall study population . In particular , neither older age nor a history of falls in the previous 12 months was associated with a higher likelihood of using osteoporosis medication . Among the 909 women who reported using a specific osteoporosis drug , vitamin D use was associated with a higher educational level and a more frequent preventive attitude . Conclusion In France , as in other western countries , women aged 75 years and over are not managed according to guidelines . Further studies should address the barriers encountered in improving quality of care in osteoporosis management OBJECTIVES To assess the effectiveness of a community-based falls- and -fracture nurse coordinator and multifactorial intervention in reducing  falls in older people . DESIGN R and omized , controlled trial . SETTING Screening for previous falls in family practice followed by community-based intervention . PARTICIPANTS Three hundred twelve community-living people aged 75 and older who had fallen in the previous year . INTERVENTION Home-based nurse assessment of falls- and -fracture risk factors and home hazards , referral to appropriate community interventions , and strength and balance exercise program . Control group received usual care and social visits . MEASUREMENTS Primary outcome was rate of falls over 12 months . Secondary outcomes were muscle strength and balance , falls efficacy , activities of daily living , self-reported physical activity level , and quality of life ( Medical Outcomes Study 36-item Short Form Question naire ) . RESULTS Of the 3,434 older adults screened for falls , 312 ( 9 % ) from 19 family practice s were enrolled and r and omized . The average age was 81+/-5 , and 69 % ( 215/312 ) were women . The incidence rate ratio for falls for the intervention group compared with the control group was 0.96 ( 95 % confidence interval=0.70 - 1.34 ) . There were no significant differences in secondary outcomes between the two groups . CONCLUSION This nurse-led intervention was not effective in reducing  falls in older people who had fallen previously . Implementation and adherence to the fall-prevention measures was dependent on referral to other health professionals working in their usual clinical practice . This may have limited the effectiveness of the interventions Summary We tested the feasibility of a fracture prevention decision aid in an online patient portal . The decision aid was acceptable for patients and successfully decreased decisional conflict . This study suggests the possible utility of leveraging the patient portal to enhance patient education and decision making in osteoporosis care . Introduction Although interventions have improved osteoporosis screening and /or treatment for certain population s of high-risk patients , recent national studies suggest that large-scale uptake of these interventions has been limited . We aim ed to determine the feasibility and potential efficacy of a patient portal-based osteoporosis decision aid ( DA ) . Methods We conducted a pilot r and omized controlled trial of primary care patients aged ≥55 who were enrolled in a patient portal and had a T-score of < −1 . Intervention subjects were provided a link to a patient DA . The DA contained a 10-year fracture risk calculator , summary of medication risks and benefits ( prescription and nonprescription ) , and an elicitation of values . Subjects completed question naires assessing the primary outcomes of decisional conflict and preparation for decision making and secondary outcomes related to feasibility and planning for a larger trial . Charts were review ed for physician-subject interactions and medication uptake . Results The DA was acceptable to subjects , but 17 % of the patients in the decision aid arm incorrectly entered their T-scores into FRAX-based risk calculator . Decisional conflict was lower post-intervention for those who were r and omized to the decision aid arm compared to controls ( 17.8 vs. 47.1 , p < .001 ) , and there was a significant difference in the percentage of patients who made a treatment decision at 3 months . No significant differences were observed in medication uptake . Conclusions A portal-based osteoporosis DA  was acceptable and improved several measures of decision quality . Given its effect on improving the quality of patients ’ decisions , future studies should examine whether it improves physician guideline adherence or medication adherence uptake among treated patients OBJECTIVES To model the incremental cost-utility of seven interventions reported as effective for preventing falls in older adults . DESIGN Mathematical epidemiological model populated by data based on direct clinical experience and a critical review of the literature . SETTING Model represents population level interventions . PARTICIPANTS No human subjects were involved in the study . MEASUREMENS : The last Cochrane data base review and meta-analyses of r and omized controlled trials categorized effective fall-prevention interventions into seven groups : medical management ( withdrawal ) of psychotropics , group tai chi , vitamin D supplementation , muscle and balance exercises , home modifications , multifactorial individualized programs for all elderly people , and multifactorial individualized treatments for high-risk frail elderly people . Fall-related hip fracture incidence was obtained from the literature . Salary figures for health professionals were based on Bureau of Labor Statistics data . Using an integrated healthcare system perspective , healthcare costs were estimated based on practice and studies on falls in older adults . Base case incremental cost utility ratios were calculated , and probabilistic sensitivity analyses were conducted . RESULTS Medical management of psychotropics and group tai chi were the least-costly , most-effective options , but they were also the least studied . Excluding these interventions , the least-expensive , most-effective options are  vitamin D supplementation and home modifications . Vitamin D supplementation costs less than home modifications , but home modifications cost only $ 14,794/ quality -adjusted life year ( QALY ) gained more than vitamin D. In probabilistic sensitivity analyses excluding management of psychotropics and tai chi , home modification is most likely to have the highest economic benefit when QALYs are valued at $ 50,000 or $ 100,000 . CONCLUSION Of single interventions studied , management of psychotropics and tai chi reduces costs the most . Of more-studied interventions , home modifications provide the best value . These results must be interpreted in the context of the multifactorial nature of falls In 673 open fractures of long bones ( tibia and fibula , femur , radius and ulna , and humerus ) treated from 1955 to 1968 at Hennepin County Medical Center , Minneapolis , Minnesota , and analyzed retrospectively , the infection rate was 12 per cent from 1955 to 1960 and 5 per cent from 1961 to 1968 . In a prospect i ve study from 1969 to 1973 , 352 patients were managed as follows : débridement and copious irrigation , primary closure for Type I and II fractures and secondary closure for Type III fractures , no primary internal fixation except in the presence of associated vascular injuries , cultures of all wounds , and oxacillin-ampicillin before surgery and for three days postoperatively . In 158 of the patients in the prospect i ve study the initial wound cultures revealed bacterial growth in 70.3 per cent and the infection rate was 2.5 per cent . Sensitivity studies suggested that cephalosporin is currently the prophylactic antibiotic of choice . For the Type III open fractures ( severe soft-tissue injury , segmental fracture , or traumatic amputation ) , the infection rates were 44 per cent in the retrospective study and 9 per cent in the prospect i ve study OBJECTIVES To investigate whether medication review s increase treatment with fracture-preventing drugs and decrease treatment with fall-risk-increasing drugs . DESIGN R and omized controlled trial ( 1:1 ) . SETTING Departments of orthopedics , geriatrics , and medicine at Sahlgrenska University Hospital , Gothenburg , Sweden . PARTICIPANTS One hundred ninety-nine consecutive individuals with hip fracture aged 65 and older . INTERVENTION Medication review s , based on assessment s of risks of falls and fractures , regarding fracture-preventing and fall-risk-increasing drugs , performed by a physician , conveyed orally and in written form to hospital physicians during the hospital stay , and to general practitioners after discharge . MEASUREMENTS Primary outcomes were changes in treatment with fracture-preventing and fall-risk-increasing drugs 12 months after discharge . Secondary outcomes were falls , fractures , deaths , and physicians ' attitudes toward the intervention . RESULTS At admission , 26 % of intervention and 29 % of control participants were taking fracture-preventing drugs , and 12 % and 11 % , respectively , were taking bone-active drugs , predominantly bisphosphonates . After 12 months , 77 % of intervention and 58 % of control participants were taking fracture-preventing drugs ( P = .01 ) , and 29 % and 15 % , respectively , were taking bone-active drugs ( P = .04 ) . Mean number of fall-risk-increasing drugs per participants was 3.1 ( intervention ) and 3.1 ( control ) at admission and 2.9 ( intervention ) and 3.1 ( control ) at 12 months ( P = .62 ) . No significant differences in hard endpoints were found . The responding physicians ( n = 65 ) appreciated the intervention ; on a scale from 1 ( very bad ) to 6 ( very good ) , the median rating was 5 ( interquartile range ( IQR ) 4 - 6 ) for the oral part and 5 ( IQR 4 - 5.5 ) for the text part . CONCLUSION Medication review s performed and conveyed by a physician increased treatment with fracture-preventing drugs but did not significantly decrease treatment with fall-risk-increasing drugs in older adults with hip fracture . Prescribing physicians appreciated this intervention OBJECTIVE To determine the effect of a home exercise program on strength , postural control , and mobility following hip fracture . DESIGN R and omized controlled trial of 1 month 's duration . SETTING Daily exercise carried out within the subjects ' home environments . PARTICIPANTS Forty-two people 64 to 94 years of age , 35 of whom were living independently in the community and 7 of whom were residing in institutional care . Subjects were recruited on average 7 months after a fall-related hip fracture and r and omly allocated to either the intervention or the control group ( n = 21 each ) . The groups were well matched in terms of medical conditions , medication use , disability , and activity levels . INTERVENTION A " home-based " program of weight-bearing exercise established at a visit by a physiotherapist . MAIN OUTCOME MEASURES Quadriceps strength , postural sway , functional reach , weight-bearing ability , walking velocity , and self-rated fall risk . The subjects undertook these assessment s at the beginning and end of the trial . RESULTS At pretest , exercisers and controls performed similarly in all tests . At the end of the trial , the intervention group showed significantly greater quadriceps strength in the affected ( hip-fractured ) leg and increased walking velocity . The intervention subjects also improved their weight-bearing ability and reported reduced subjective falls risk . In contrast , there were no significant improvements in any of the test measures in the controls . Within the intervention group , improvements in quadriceps strength were significantly associated with improved performances in the weight-bearing test measures and with increased walking velocity . CONCLUSIONS This exercise program improved strength and mobility following hip fracture . Further research is needed to ascertain whether the extent of this improvement in these fall risk factors is sufficient to prevent falls A r and omized controlled trial was performed to examine the cost-effectiveness of external hip protectors in the prevention of hip fractures . Since the hip protectors were not effective in preventing hip fractures in our study , the main objective became to examine whether the use of hip protectors results in lower average costs per participant in the  hip protector group as compared with the control group . In addition , the average costs of a hip fracture and subsequent rehabilitation in frail , institutionalized elderly were calculated . Residents from apartment houses for the elderly , homes for the elderly and nursing homes with a high risk for hip fractures were r and omized to the hip protector group ( n=276 ) or control group ( n=285 ) . Costs were calculated for the hip fracture and subsequent rehabilitation until 1 year after the fracture . Six months after each hip fracture , a nurse was interviewed and after 12 months , a question naire was sent to the general practitioner or nursing home physician to determine the utilization of health care re sources . Differences in costs between the groups were analyzed using non-parametric bootstrapping . Eighteen hip fractures occurred in the intervention group and 20 hip fractures ( in 19 persons ) in the control group ( log rank P-value=0.86 ) . The average costs per participant , including the costs of the intervention , were € 913 in the intervention group and € 502 in the control group ( cost difference of € −411 ; 95 % confidence interval : −723 ; 57 ) . The average costs of a hip fracture and subsequent rehabilitation were € 8100 ( 95 % CI : 6716–10,010 ) . The use of hip protectors was not associated with lower costs . In addition , the average costs of a hip fracture and subsequent rehabilitation in the first year after the fracture were estimated at € 8100 in institutionalized elderly BACKGROUND calcium and vitamin D deficiency are common in elderly people and lead to increased bone loss , with an enhanced risk of osteoporotic fractures . Although hip fractures are a serious consequence , few therapeutic measures are given for primary or secondary prevention . A combination of calcium and vitamin D may not be the most effective treatment for all patients . OBJECTIVE to investigate the effects of hypovitaminosis D on the calcium-parathyroid hormone endocrine axis , bone mineral density and fracture type , and the optimal role of combination calcium and vitamin D therapy after hip fracture in elderly patients . DESIGN a population -based , prospect i ve cohort study . METHODS 150 elderly subjects were recruited from the fast-track orthogeriatric rehabilitation ward within 7 days of surgery for hip fracture . This ward accepts people who live at home and are independent in activities of daily living . All subjects had a baseline medical examination , biochemical tests ( parathyroid hormone ,  25-hydroxyvitamin D  and  1,25-dihydroxyvitamin D ) and were referred for bone densitometry . RESULTS at 68 % , the prevalence of hypovitaminosis D ( 25-hydroxyvitamin D<30 nmol/l ) was high . However , only half the patients had evidence of secondary hyperparathyroidism , the rest having a low to normal level of parathyroid hormone ( ' functional hypoparathyroidism ' ) . Patients with secondary hyperparathyroidism and hypovitaminosis D had a higher mean corrected calcium , higher 1,25-dihydroxyvitamin D , lower hip bone mineral density and an excess of extracapsular over intracapsular fractures than the ' functional hypoparathyroid ' group ( P<0.01 ) . CONCLUSION there is a high prevalence of hypovitaminosis D in active , elderly people living at home who present with a hip fracture . However , secondary hyperparathyroidism occurs in only half of these patients . This subgroup attempts to maintain calcium homeostasis but does so at the expense of increased bone turnover , leading to amplified hip bone loss and an excess of extracapsular over intracapsular fractures .  Combination calcium and vitamin D treatment may be effective in preventing a second hip fracture in these patients , but its role in patients with hypovitaminosis D without secondary hyperparathyroidism and ' vitamin D-replete ' subjects needs further evaluation BACKGROUND Osteoporosis-related fractures are a considerable economic burden on the U.S. health care system . Since 2008 , the Centers for Medicare Medicaid Services have adopted a Medicare Part C Five-Star Quality Rating measure to ensure that a woman 's previously unaddressed osteoporosis is managed appropriately after a fracture . Despite the effort to improve this gap in care , the 2013 CMS plan ratings fact sheet reported an average star rating of 1.4 stars for the osteoporosis measure , the lowest score for any measure across all health plans . OBJECTIVE To evaluate the impact of conducting a pharmacist-led , telephone outreach program to members or their providers to improve osteoporosis management in elderly women after experiencing fractures . METHODS This was a prospect i ve , r and omized study to evaluate the effectiveness of 3 different intervention strategies within a nationwide managed care population . Women aged 66 years and older who experienced a new bone fracture between January 1 , 2012-August 31 , 2012 , were identified through medical cl aims . Women who were treated with an osteoporosis medication or received a bone mineral density ( BMD ) test within a year of their fractures were excluded . Study patients were r and omized into 3 intervention cohorts : ( 1 ) baseline intervention consisting of member educational mailing and provider educational mail or fax notification ; ( 2 ) baseline intervention plus a live outbound intervention call to members by a pharmacist ; and ( 3 ) baseline intervention plus a pharmacist call to members ' providers to recommend starting osteoporosis therapy and /or a bone mineral density ( BMD ) test . An intent-to-treat and per protocol analyses were employed , and appropriate osteoporosis management ( initiation of osteoporosis therapy and /or BMD testing ) 120 days after the baseline intervention and 180 days after a fracture were measured . RESULTS The study identified 6,591 members who were equally r and omized into 3 cohorts . The baseline demographics in each cohort were similar . Results of the intent-to-treat analysis showed more members in cohort 3 receiving appropriate osteoporosis management ( 13.0 % ) compared with those in cohort 2 ( 10.3 % , P less than 0.005 ) or compared with those in cohort 1 ( 9.1 % , P less than 0.001 ) . No difference was detected between those receiving additional member calls ( cohort 2 ) and those receiving only the baseline intervention ( cohort 1 ) . Similar results were observed utilizing the 180 days after fracture time frame . CONCLUSIONS The effectiveness of a pharmacist-led telephone intervention directed at providers or members was examined in this r and omized study . Pharmacist calls to members did not improve osteoporosis management over member and provider mail and fax notifications . Greater impact was demonstrated by performing a pharmacist call intervention with providers rather than with members BACKGROUND Multiple studies demonstrate poor adherence to medication regimens prescribed for chronic illnesses , including osteoporosis , but few interventions have been proven to enhance adherence . We examined the effectiveness of a telephone-based counseling program rooted in motivational interviewing to improve adherence to a medication regimen for osteoporosis . METHODS We conducted a 1-year r and omized controlled clinical trial . Participants were recruited from a large pharmacy benefits program for Medicare beneficiaries . All potentially eligible individuals had been newly prescribed a medication for osteoporosis . Consenting participants were r and omized to a program of telephone-based counseling ( n = 1046 ) using a motivational interviewing framework or a control group ( n = 1041 )  that received mailed educational material s.  Medication regimen adherence was the primary outcome compared across treatment arms and was measured as the median ( interquartile range ) medication possession ratio , calculated as the ratio of days with filled prescriptions to total days of follow-up . RESULTS The groups were balanced at baseline , with a mean age of 78 years ; 93.8 % were female . In an intention-to-treat analysis , median adherence was 49 % ( interquartile range , 7%-88 % ) in the intervention arm and 41 % ( 2%-86 % ) in the control arm ( P = .07 , Kruskal-Wallis test ) . There were no differences in self-reported fractures . CONCLUSION In this r and omized controlled trial , we did not find a statistically significant improvement in adherence to an osteoporosis medication regimen using a telephonic motivational interviewing intervention Context Despite evidence to support the effectiveness of a variety of interventions for the secondary prevention of cardiovascular disease , many eligible patients do not receive these interventions . Contribution Compared with a baseline period , patients hospitalized with cardiovascular disease who received an  intervention that focused on discharge medications had higher rates of prescription of aspirin , -blockers , statins , angiotensin-converting enzyme inhibitors , and warfarin at hospital discharge . The risk for death and readmission was lower in the intervention period than in the baseline period . Caution s The prepost design of this study does not permit conclusions about a causal relationship between the intervention and the observed improvements . The Editors Cardiovascular disease remains the most common source of morbidity and mortality in western countries ( 1 ) . During the past 2 decades , a variety of significant medical advances have been made in the treatment and prevention of complications associated with major cardiovascular disorders , including coronary artery disease , congestive heart failure ( CHF ) , and atrial fibrillation . Many of these advances in secondary prevention relate simply to the appropriate use of certain medications , for example , aspirin and statins for coronary artery disease , -blockers and angiotensin-converting enzyme inhibitors for CHF , and warfarin for prevention of stroke and other embolic events in patients with atrial fibrillation . Each of these medical therapies has been proven in large , multicenter , r and omized , double-blind , placebo-controlled trials to save lives under appropriate circumstances ( 2 - 7 ) . However , despite the overwhelming evidence supporting the benefit of these medications , many studies have documented a significant treatment gap . Often , far fewer than 50 % of potential beneficiaries actually receive treatment ( 8 - 13 ) , and studies from our institution and others have shown that many patients do not receive indicated medications at hospital discharge ( 14 , 15 ) . On the other h and , the chances of long-term adherence are significantly higher when medications are provided at hospital discharge , and this difference is associated with decreased mortality rates ( 13 , 16 ) . Hospital discharge is a critical juncture in the process of care . Patients are available for consultation and are often more disposed to adopt health care recommendations . A hospital dischargebased intervention could be more easily implemented , more effectively managed and measured , and more cost-effective than other potential outpatient intervention strategies . Consequently , there is substantial justification for focusing on hospital discharge as the ideal time to improve prescription of medications for secondary prevention of cardiovascular disease . In the current study , our objectives were to 1 ) determine the feasibility of implementing a comprehensive quality improvement initiative in a large multihospital network to significantly increase rates of prescription at discharge of evidence -based , secondary prevention medications for life-threatening cardiovascular diseases ; 2 ) ascertain the effect of such a program on long-term clinical outcomes ; and 3 ) determine whether good adherence to such an initiative is sustainable . Methods Intermountain Health Care ( IHC ) is a nonprofit , integrated health care system including 20 hospitals , a system of health plans , and both employed and affiliated physicians . The approximately 400 employed physicians mainly practice primary care , and the approximately 2500 affiliated physicians are mostly specialists . Intermountain Health Care serves approximately 60 % of the population of Utah and southern Idaho . The system 's 10 largest hospitals were included in the quality improvement initiative , accounting for more than 90 % of the total population of cardiovascular patients . The major intent of this initiative was to ensure that appropriate secondary prevention medications were prescribed at discharge to all patients ( excluding those with documented contraindications ) who were hospitalized with a principal cardiovascular diagnosis of acute myocardial infa rct ion ( MI ) , coronary heart disease ( CHD ) , CHF , or atrial fibrillation . Table 1 shows the guidelines that were developed for each of the diagnostic categories , and Appendix Figure 1 shows the reference card that was developed to aid physicians and clinical staff . All of the guidelines were based on the current class IA American Heart Association/American College of Cardiology recommendations , except for the recommendation of a statin in all patients with CHD , including those with a low-density lipoprotein cholesterol level less than 2.59 mmol/L ( < 100 mg/dL ) . Our research ( 17 ) showed that a statin provided significant benefit in this population , a notion that has since been supported by a large clinical trial ( 18 ) . -Blocker therapy for patients with CHF was deferred until after discharge . Table 1 . Discharge Medication Guidelines for the Secondary Prevention of Cardiovascular Disorders Design and Implementation of the Quality Improvement Program In 1998 , before the new discharge medication program ( DMP ) was initiated , a new institution-wide data base was developed to assist in its implementation and long-term management . Simultaneously , all participating institutions began prospect ively tracking prescription of applicable discharge medications for all cardiac patients discharged from their respective cardiovascular departments ( Appendix Figure 2 ) . The DMP was implemented on 1 January 1999 , and tracking of discharge prescriptions continued . Maintenance of the discharge medication data base is ongoing , and information through February 2002 was included in this study . Appendix Figure 2 . Data collection form for the discharge medication program . Implementation of the DMP required support and commitment from every level of the health care system , including administration , physicians , nurses , and other staff . To gain this support , the IHC Cardiovascular Clinical Program leadership conducted an extensive education campaign in all participating hospitals . Before the actual initiation of the DMP , this group conducted an extensive tour to engage physicians , residents , and nurses with the program , its goals , and its rationale . The actual DMP implementation and documentation process varied from hospital to hospital but always included the essential core elements . The appropriate indication for each medication was printed directly on the patient discharge form , so physicians needed only to check the correct box or record the specific contraindication ( Appendix Figure 3 ) . This form served as a project management and data collection tool . When an appropriate medication was not prescribed , the discharge-planning nurse contacted the attending physician or resident directly , after which the missing medication could be added to the discharge prescriptions or an appropriate contraindication for its use could be documented . All information was entered into a computerized data base for tracking . Other than the additional re sources for data management , the DMP used existing hospital personnel . No organized effort was made to guarantee long-term adherence to prescribed medications after discharge . Appendix Figure 2 . Discharge orders form .. Documentation of Short-Term Success of the Program To measure and manage the short-term success of the program , monthly reports were generated showing the proportion of cardiovascular patients discharged with prescriptions for the indicated secondary prevention medications at each of the 10 hospitals . These reports were shared extensively with all participating health care providers from each contributing institution in an effort to further increase adherence . Long-Term Follow-up To monitor the effect of DMP implementation on long-term clinical outcomes , the baseline characteristics ( age , sex , and discharge diagnosis ) of each cardiovascular patient discharged from the 10 participating facilities were compiled from the central ized IHC informatics data base . Each patient was followed prospect ively for up to 1 year for hospital readmission due to a cardiovascular indication or for death . If no evidence of hospital readmission or death could be found for a patient , we assumed that the patient had not experienced either event . Information was included from 1996 , 3 years before DMP  initiation , to February 2002 , more than 3 years afterward . Rehospitalizations ( cardiovascular only ) were determined through the IHC informatics system 's electronic data warehouse , and death was ascertained by using the IHC system and the Social Security Administration 's death records . Such electronic follow-up , in our experience ( 16 ) , has proven more thorough and accurate than telephone surveys . Although a limited proportion of patients may have been readmitted to other hospitals for subsequent care , they were probably r and omly distributed between the pre-DMP and DMP sample s. Characteristics of patients admitted before ( 1996 to 1998 ) and after ( 1999 to 2002 ) DMP implementation were evaluated separately and compared . Statistical Analysis The chi-square test was used to evaluate differences in the proportions of patients receiving appropriate discharge prescriptions  in the  pre-DMP and DMP groups . To evaluate the effect of the DMP , we formed 4 mutually exclusive diagnostic or procedural categories for patients with the following index admissions : CHD without CHF , MI , or coronary artery bypass grafting ( CABG ) ; CHF without MI or CABG ; MI without CABG ; and CABG . The category of atrial fibrillation was not mutually exclusive of the other 4 categories . These categories reflected different patient sample s and were not design ed to evaluate groups on the basis of indications for each separate medication , since more than 1 medication could have been indicated in any given patient . Differences between baseline characteristics of the pre-DMP and DMP groups were
Applying different numerator and denominator combinations meant that the same observed number of patients could have result ed in different reported rates .
OBJECTIVE To examine the methods used to calculate the reported medication initiation rates in secondary fracture prevention programs .