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

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.