Status:
COMPLETED
Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy
Lead Sponsor:
Sanofi
Conditions:
Osteoporosis
Eligibility:
All Genders
30-85 years
Phase:
PHASE4
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
- 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
- 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.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00616694
Start Date
July 1 2002
End Date
December 1 2004
Last Update
February 21 2008
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807