# Presentation: 006025

## OsteoporosisStrategies for Screening and InterventionMarch 2, 2005

- Steven R. Brown, MD
- Family Physician,
- Whiteriver Indian Health Service
- Roy Teramoto, MD, MPH
- Maternal Child Health Consultant
- Phoenix Area Indian Health Service

## Definition

-   A skeletal disorder characterized by compromised bone strength predisposing to an increased risk of fracture.
-     NIH Consensus Statement 2000

## Diagnostic Criteria

- Bone mineral density (BMD) 2.5 standard deviations below the mean bone mineral density of healthy, young, white women
-    (T-score of -2.5) or
- Fracture in the absence of significant trauma in a postmenopausal woman
-     World Health Organization working group 1992

## Diagnostic Criteria

- Osteopenia – BMD 1 to 2.5 standard deviations below the mean (T-score -1.0 to -2.5)
- Unclear clinical value – wide range of fracture risk found among women in this category

## Gold Standard

-    Central DEXA scan for bone mineral density,  BUT ***true*** “gold standard” is fracture/fracture rates for public health purposes.

## Epidemiology

- Rates vary among racial and ethnic groups
- Data is best established for Caucasian females
- Limited data available regarding osteoporosis and fracture rates in American Indian and Alaska Natives
- Data suggests that they are at least as great a problem as for the general population

## Epidemiology

-    National Osteoporosis Risk Assessment (NORA)
-    Study of peripheral osteoporosis
-       screening
-    1708 “Native American” women – risk
-        of fracture over life of the study was the
-        same as that of “white” women

## Epidemiology

-    Small study in the Sac and Fox Nation of Oklahoma
-       Lower BMD in postmenopausal
-      women as measured by central
-      DEXA than that reported for “white”
-      women
-     The effect of aging on bone mineral metabolism and bone mass in Native American Women, _J Am Geriatr Soci _1998; 46:
-     1418-22

## Hip Fracture Risk by Race/EthnicityRelative Hazard (95% Confidence interval)

- White 1.00 (referant)
- African American 0.54 (0.41-0.72)
- Native American 0.89 (0.59-1.34)
- Hispanic 0.91 (0.72-1.15)
- Asian 0.41 (0.21-1.79)

## Epidemiology

-    Review of hip fractures at Alaska Native Medical Center
-    Higher fracture rates than reported for white US women during the periods of 1979-1989 and 1996-1999
-     Incidence of hip fracture in Alaska Inuit people, _Alaska Med;_ 2001, 43: 2-5

## Risk Factors for Osteoporosis (AI/AN)

- Low calcium intake
- Sedentary lifestyle
- Issues with body mass index
- Smoking
- Osteoporosis in Native Americans, _IHS Provider _2002;
- 94: 94-101

## Clinical Risk Factors for Hip Fracture

- Skeletal
- History of maternal hip fracture (RR=2.0)
- Age, per 5 year (RR=1.5)
- Current cortisone use (RR=1.57)
- Current smoking (RR=1.14 - 2.1)
- Low Body Mass Index (BMI >30 has RR 0.16 of having osteoporosis)
- Race (African-American RR= 0.54)

## Skeletal status by age

## Clinical Risk Factors for Hip Fracture

- Use of anticonvulsant drugs (RR=2.8)
- Serious long-term conditions thought to increase fracture risk such as hyperthyroidism or malabsorption

## Clinical Risk Factors for Hip Fracture

- Non-skeletal
- Poor vision (RR=1.5)
- Inability to rise from chair (RR=2.1)
- Benzodiazapine use (RR=1.6)
- Fall in the previous year (RR=1.6)
- Self-rated health status of fair/poor (RR=1.79)

## The Osteoporosis Pyramid1

## Risk Factors for Falls

-         Risk Factor       Mean RR-OR
- Muscle weakness                 4.4
- History of falls                     3.0
- Gait deficit                           2.9
- Balance deficit                      2.9
- Use assistive device              2.6
- Visual deficit                        2.5
- From:  Guidelines for the Prevention of Falls in Older Persons, _Journal of the American Geriatric Society_ 49:664-672, 2001

## Approach to Older Persons as Part of Routine Care (Not Presenting After A Fall)

- All older persons who are under the care of a health professional (or their caregivers) should be asked at least once a year about falls.
- All older persons who report a single fall should be observed as they stand up from a chair without using their arms, walk several paces, and return (i.e., the “Get Up and Go Test”).  Those demonstrating no difficulty or unsteadiness need no further assessment.
- From:  Guidelines for the Prevention of Falls in Older Persons, _Journal of the American Geriatric Society_ 49:664-672, 2001

## Approach to Older Persons as Part of Routine Care (Not Presenting After A Fall)

- Persons who have difficulty or demonstrate unsteadiness performing this test require further assessment.
- From:  Guidelines for the Prevention of Falls in Older Persons, _Journal of the American Geriatric Society_ 49:664-672, 2001

## Approach to Older Persons Presenting with One or More Falls or Have Abnormalities of Gait and/or Balance, or Who Report Recurrent Falls

- Older persons who should have a fall evaluation performed:
- Present for medical attention because
-    of a fall
- Report recurrent falls in the past year
- Demonstrate abnormalities of gait and/or
-    balance.

## Approach to Older Persons Presenting with One or More Falls or Have Abnormalities of Gait and/or Balance, or Who Report Recurrent Falls

- Fall Evaluation
- Should be performed by a clinician with appropriate skills and experience
- May necessitate referral to a specialist (e.g., geriatrician).

## Approach to Older Persons Presenting with One or More Falls or Have Abnormalities of Gait and/or Balance, or Who Report Recurrent Falls

- Fall evaluation
- Assessment that includes the following:
-      A history of fall circumstances
-      Medications
-      Acute or chronic medical problems
-      Mobility levels
-      Examination of vision
-      Examination of gait, balance and lower extremity joint
-          function

## Approach to Older Persons Presenting with One or More Falls or Have Abnormalities of Gait and/or Balance, or Who Report Recurrent Falls

- Examination of basic neurological function
-  Mental status
-  Muscle strength
-  Lower extremity peripheral nerves
-  Proprioception
-  Reflexes
-  Tests of cortical, extrapyramidal, and
- cerebellar functions

## Approach to Older Persons Presenting with One or More Falls or Have Abnormalities of Gait and/or Balance, or Who Report Recurrent Falls

- Assessment of basic cardiovascular status including heart rate and rhythm
-   Postural pulse and blood pressure
-   If appropriate, heart rate and blood
-  pressure responses to carotid
-  sinus stimulation.

## Approaches Demonstrating Benefit

- Muscle strengthening and balance retraining
- Professional home hazard assessment and modification
- Stopping or reducing psychotropic medication
- _NEJM_ 348: 42-9, 2003; _NEJM_ 331: 821-7, 1994
- Note:  Optimal duration or intensity of these  approaches have not been defined

## Hip Protectors/Pads

- Hip protectors reduce the risk of hip fracture for elderly individuals who live in nursing homes and residential care facilities, as well as those in supported living at home
- The generalization of the results beyond this high risk population is unknown

## Hip Protectors/Pads

- One study found that 41 patients would need to be offered treatment with a hip protector to prevent one hip fracture over the course of one year (_NEJM_ 343: 1506-13; 2000)
- Hip protectors may be a reasonable and cost-effective option for patients at high risk of falls.

## Hip Protectors/Pads

- Randomized controlled trial among women over 70 living in the community found that hip protectors offered no significant reduction in the risk of hip fracture (Birks -_Osteoporos Int_ 2004, Mar 3)
- Compliance rates were quite low (about 30%)
- Need for more acceptable, easy-to-use devices that can protect fragile bones

## Slide 29

## The Third Level of the Pyramid:  Medical Interventions

- Bisphosphonates
- Alendronate
- Risedronate
- Calcium + Vitamin D
- Calcitonin
- Estrogen
- Selective estrogen receptor modulator (Raloxifene)
- Teriparatide (recombinant human parathyroid hormone)

## POEM vs. DOE

- POEM:  Patient Oriented Evidence that Matters
- Hip and Vertebral Fractures
- DOE:  Disease Oriented Evidence
- Bone Density

## Intervention:  Alendronate

- In postmenopausal women with osteoporosis does alendronate compared to placebo reduce hip and vertebral fractures?
- Answer:  Good evidence based on randomized, controlled trials...

## Treatment of Osteoporosis:The Fracture Intervention Trial2 (FIT)

## FIT:  Hip fracture

- Population:  3658 white women age 55-80 with osteoporosis (femoral-neck T-score <-2.5 or existing vertebral fracture.)
- 		* = achieved statistical significance

## FIT:  Vertebral Fracture

- Population:  3658 white women age 55-80 with osteoporosis (femoral-neck T-score <-2.5 or existing vertebral fracture.)
- 		* = achieved statistical significance

## FIT:  Number Needed to Treat (NNT)

## Alendronate:  Harms

- “Esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with **alendronate** sodium. In some cases these have been severe and required hospitalization.”3
- One RCT found that when taken correctly, there was no significant difference in esophagitis with alendronate versus placebo4
- From the SG:  “appears to be safe and effective for up to 10 years.”

## Interventions

- Calcium and Vitamin D
- In mobile elderly women in nursing homes does Calcium and Vit D compared to placebo reduce hip fracture?
- Yes, quite impressively.
- The NNT at 3 years to prevent one hip fracture in this population is 25.
- NNT at 18 months to prevent one hip fracture is 50.

## Ref 5

## Key Question #1 in the analytic framework from the USPSTF 5

- Does screening for osteoporosis using risk factor assessment or bone density testing reduce fractures?
- USPSTF answer:  “We identified no studies about the effectiveness of screening in reducing osteoporotic fractures.”
- Therefore:  “Recommendations about screening need to rely on evidence that risk factor assessment or bone density testing can adequately identify women who could ultimately benefit from treatment.”

## Risk Factor Screening

- Osteoporosis Risk Assessment Instrument (ORAI)6 is one of two validated risk factor assessment tools given a “good” quality rating by the USPSTF5
- 95 % sensitive and 41 % specific for detecting hip or lumbar spine BMD T-score <-2.5.

## Risk Factor Screening

- ORAI scoring6

## Radiologic Screening Methods

- DXA (dual energy x-ray absorptiometry)
- Hip
- Spine
- Peripheral Densitometry (DXA or SXA)
- Distal radius
- Calcaneus
- Finger
- Quantitative Computed Tomography
- Spine
- Quantitative Ultrasound
- Calcaneus
- Tibia

## “Looking to the future...” 1

## Radiologic Screening Methods

- 1996 BMJ meta-analysis7 showed all measuring sites had similar predictive abilities for fracture.
- RR 1.5 (CI 1.4-1.6) for 1 SD decrease in BMD for age (Z-score) except:
- Measurement at spine for vertebral fractures:  RR 2.3 (CI 1.9-2.8)
- Measurement at hip for hip fractures:  RR 2.6 (CI 2.0-3.5)

**Notes:**
RR of 1.5 = 50%increase in risk, RR of 2 is double risk

## Screening Methods

- As stated by the USPSTF:  “the probability of receiving a diagnosis of osteoporosis depends on the choice of test and site.”
- USPSTF: “the likelihood of receiving a diagnosis of osteoporosis also depends on the number of sites tested.”
- National Osteoporosis Risk Assessment8:
-  the probability of having osteoporosis varied from 3.4% (heel ultrasound) to 13.5% (finger DXA) depending on site tested and method of testing.
- Odds of osteoporosis by site tested:  Heel ultrasound OR 0.79, DXA at forearm or finger OR 2.86, 4.82.

## Screening Methods

- Again from the USPSTF:  “DXA is considered the gold standard because it is the most extensively validated test against fracture outcomes.”
- Randomized, controlled trials, such as FIT, use femoral neck DXA to identify patients with osteoporosis that might benefit from therapy.

## Number needed...

## Number needed to screen5

## Screening Methods:  Ultrasound

- EPIDOS 9:  1996 prospective study of 5662 elderly women with 115 hip fractures in average follow-up of two years
- Patients had calcaneal ultrasound (Lunar Corp.) and femoral DXA
- Relative risk of hip fracture for 1 SD reduction
- in ultrasound attenuation at heel 2.0 (CI 1.6-2.4)
- in hip BMD 1.9 (CI 1.6-2.4)
- Author conclusions: Calcaneal ultrasound “predicts the risk of hip fracture as efficiently as DXA.”

## Screening Methods:  Ultrasound

- The 1997 Study of Osteoporotic Fractures Research Group10 followed 6189 women over 65 for an average of 2 years
- 54 hip fractures
- Calcaneal quantitative ultrasound (Walker-Sonix) and hip and calcaneal DXA were performed
- Relative risk of hip fracture for 1 SD reduction
- In heel ultrasound attenuation 2.0 (1.5-2.7)
- In hip BMD 2.6 (1.9-3.8)
- Author conclusion:  “the strength for the association between BUA and fracture is similar to that observed with bone mineral density.”

## An ultrasound study in primary care11

- 200 women age 60-69 in British general practice had DXA and heel ultrasound (Sahara) and risk factor screening
- Ultrasound T-score <1.7 SD (lowest quartile) compared to a “gold standard” of osteoporosis on DXA yielded
- sensitivity of 71% and specificity of 83%
- PPV of 45% and NPV of 94%
- 16.3 % of patients had osteoporosis
- Including risk factor screening
- Sensitivity 90%, specificity 38%
- PPV 22%, NPV 95%

## A Public Health Approach to a Fracture Prevention Program at Your Service Unit

- Why?
- It will help your patients “live long and live well.”
- October 2004:  “The intent of this Surgeon General’s Report is to serve as a catalyst for the development of a public health approach to promoting bone health.”
- The Surgeon General urges: “implement a comprehensive, systems-based approach to promoting bone health.”
- 2002-2011 Decade of Bone and Joint
- Healthy People 2010
- “reduce the number of individuals with osteoporosis and hip fractures...”
- HEDIS, GPRA

## Outcomes and Cost/EffortDesigning an approach at your Service Unit

## Slide 56

## Designing a Fracture Prevention Approach at your Service Unit

- Avoid pitfalls
- No screening program
- Not identifying and treating the highest risk individuals
- Not appropriately utilizing cost/effort
- Focusing on unproven technologies if DEXA is available
- Remember the pyramid

## Fracture Prevention Program:  Avoiding Pitfalls

- Pitfall #1:  No screening program

## Fracture Prevention Program: Avoiding Pitfalls

- Pitfall #2:  Not identifying and treating the highest-risk individuals
- Consider secondary osteoporosis (e.g. ESRD, rheumatoid arthritis, steroid use)
- Treat patients with fragility fractures (the “sentinel event”)
- Only 22-24% of patients with fractures treated in two recent studies
- A recent controlled trial showed improved treatment after fracture with faxed reminders to physicians (still only 40%).
- Do not delay treatment for imaging
- Screen women over 75 and frail elderly first

## Fracture Prevention Program: Avoiding Pitfalls

- Pitfall #3:  Not appropriately utilizing cost and effort
- Do not prioritize screening young, well-nourished, otherwise healthy, women.
- Initiate population screening no earlier than 65 years of age

## Number needed to screen5

## Fracture Prevention Program: Avoiding Pitfalls

- Pitfall #4:  Focusing on unproven technologies if DEXA is available

## Fracture Prevention Program: Avoiding Pitfalls

- Pitfall #5:  Remember the Pyramid! (and don’t invert it.)
- Use Calcium
- NNT in some populations 25

## “When so many hours have been spent in convincing myself that I am right, is there not some reason to fear I may be wrong?”

- - Jane Austen

## References

- US Dept of HHS.  Bone health and osteoporosis:  A Report of the Surgeon General.  Rockville, MD:  HHS, Office of the Surgeon General, 2004.
- Black DM, et al.  Fracture risk reduction with alendronate in women with osteoporosis:  The fracture intervention trial.  J Clin Endocrinol Metab 2000;85:4118-4124.
- Mosby’s Drug Consult 2003, accessed on mdconsult.com 12/1/03
- Bruyere O, et al.  Fracture prevention in postmenopausal women. Clinical Evidence 2003; 9.  BMJ Publishing Group.
- Nelson HD, et al.  Screening for postmenopausal osteoporosis: a review of the evidence for the USPSTF.  Ann Intern Med 2002;137:529-41.
- Cadarette SM, et al.  Development and validation of the Osteoporosis Risk Assessment Instrument to facilitate selection of women for bone densitometry.  CMAJ 2000;162(9):1289-1294.
- Marshall D, Johnell O, Wedel H.  Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures.  BMJ 1996;312:1254-59.
- Siris ES, et al.  Identification and fracture outcomes of of undiagnosed low bone mineral density in postmenopausal women.  Results from the National Osteoporosis Risk Assessment.  JAMA 2001;286:2815-2822.

## References

**References**

- Hans D, et al.  Ultrasonographic heel measurements to predict hip fracture in elderly women:  the EPIDOS prospective study.  Lancet 1996;348:511-514.
- Bauer DC, et al.  Broadband ultrasound attenuation predicts fractures strongly and independently of densitometry in older women.  Arch Intern Med 1997;157:629-634.
- Hodson J, Marsh J.  Quantitative ultrasound and risk factor enquiry as predictors of postmenopausal osteoporosis: comparative study in primary care.  BMJ 2003;326:1250-1251.