IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)
Phase 3
Completed
- Conditions
- Osteoporosis
- Registration Number
- NCT00268632
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Ambulatory women,
- Caucasian, Oriental or Multiracial
- not previously diagnosed for osteoporosis.
Exclusion Criteria
- Females of black descent and for the US african american are excluded because of the very low incidence of postmenopausal osteoporosis
- and having used oral or parenteral glucocorticoids (>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO. collected at week 10 and 22
- Secondary Outcome Measures
Name Time Method to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis During the study conduct to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX) after 10 and 22 weeks of treatment To assess the change in BMD of both total hip and lumbar spine; at week 52 compared to baseline osteoporosis-related genotyping. During the study conduct