Overview

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.