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

Completed · Phase 4

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00616694

Run by

Sanofi

People needed

248

Starts

2002-07-01

Expected to finish

2004-12-01

Last updated by the study team

2008-02-21

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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