Clinical trial NCT00616694: Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy
Official title: A Randomized Multicenter Parallel Group Study to Determine if Knowledge of Baseline Vertebral Fracture Prevalence (as Determined by Hologic IVA) and Bone Turnover Marker Determinations Improves Persistence With Actonel 5mg Daily Therapy in Subjects Receiving Chronic Glucocorticoid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 248
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of subject knowledge of their disease status on persistence in subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment of GIO.


Eligibility criteria: Inclusion Criteria:

* Subjects with a variety of rheumatologic, pulmonary, and skin conditions.
* Subjects were to be on oral glucocorticoids with a mean daily dose of greater than or equal to 5.0 mg prednisone (or its equivalent) and were expected (although not required) to remain on a daily dose of greater than or equal to 5.0 mg prednisone (or its equivalent) for 12 months after the study started.
* Women must have been at least one year post-menopausal or surgically sterile.
* Subjects must have had evaluable BMD site at the lumbar spine (LS) and proximal femur.

Exclusion Criteria:

* Subject's unwillingness to take Vitamin D, calcium supplements or study medication
* A history of cancer: any history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the subject has been in remission for at least 6 months prior to enrollment.
* A history of hyperparathyroidism, hyperthyroidism or osteomalacia or other metabolic bone disease within one year prior to enrollment
* History of alcohol or drug dependence within one year of enrollment
* A history of using any of the following medications within 6 months of starting study drug: Estrogen or estrogen-related drugs (tamoxifen, raloxifene, tibolone); low dose vaginal estrogen (estradiol \< 0.2 mg/day, estropipate \< 1.5 mg/day) will be allowed,Anabolic steroids,Parathyroid hormone
* A history of using any of the following medications within 1 month of starting study drugor for more than 1 month within 6 months prior to study entry: Calcitonin,Vitamin D supplements (\>1000 IU per day),Calcitriol (\>1.5mcg/week)
* A history of using any of the following medications within 6 months of starting study drug or for more than 14 days within 1 year prior to study entry: Any bisphosphonate,Fluoride (\> 10 mg per day),Estrogen implant,Deflazacort
* Have received a depot injection of \> 10,000 IU Vitamin D in the past 12 months
* Have a documented history of an abnormal or allergic reaction to bisphosphonates
* History of recurrent nephrolithiasis or a history of one episode of nephrolithiasis within 5years of study entry
* Severe renal impairment (creatinine clearance of \<30 mL/min)
* Subjects on steroid therapy for transplantation
* Subjects on oral glucocorticoids for \>8 weeks but \<6 months at screening
* History of hypersensitivity to the investigational product or to drugs with similar chemical structures
* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Determine whether subject knowledge of baseline vertebral fracture prevalence and awareness of results of bone turnover marker (BTM)determinations would result in an increase in persistence with Actonel 5 mg daily therapy
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate relationship between prevalence of vertebral fractures and duration of prior steroid therapy, amount of prior steroid therapy, and diagnosis of disease for which steroids were used
timeFrame: 12 months
measure: To evaluate the correlation between baseline vertebral fracture prevalence and subject persistence with Actonel 5 mg daily
timeFrame: 12 months
measure: Evaluate influence of Actonel 5 mg on BTM determinations and bone mineral density(BMD) at study finish relative to baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Phyllis Diener
role: STUDY_DIRECTOR
References: