Osteoporosis
Conditions
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.
Interventions
DRUGActonel
Actonel 5 mg orally once daily (OD), calcium 500 mg + vitamin D 200 units twice daily (BID)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 12 months |
| To evaluate the correlation between baseline vertebral fracture prevalence and subject persistence with Actonel 5 mg daily | 12 months |
| Evaluate influence of Actonel 5 mg on BTM determinations and bone mineral density(BMD) at study finish relative to baseline | 12 months |
Countries
United States
Outcome results
None listed