Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glucocorticoids; Risedronate Sodium; Risedronic Acid

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.