Expired Study
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Bridgewater, New Jersey 08807


Purpose:

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.


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.


NCT ID:

NCT00616694


Primary Contact:

Study Director
Phyllis Diener
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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