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

NCT ID: NCT00616694

Last Updated: 2008-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2004-12-31

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Actonel

Actonel 5 mg orally once daily (OD), calcium 500 mg + vitamin D 200 units twice daily (BID)

Intervention Type: DRUG

Other Intervention Names

Risedronate Sodium

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Phyllis Diener

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

HMR4003B_4027

Identifier Type: -

Identifier Source: org_study_id