impact of vertebral fracture knowledge on persistence in subjects taking glucocorticoid therapy

Conditions: Osteoporosis

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.