Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover
Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Women With Osteoporosis
Intervention: Risedronate (Drug); Placebo/Risedronate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Warner Chilcott Official(s) and/or principal investigator(s): Herman Ellman, MD, Study Director, Affiliation: Warner Chilcott
Summary
The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on
BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.
Clinical Details
Official title: A 1-year, Risedronate-free, Multicenter, Outpatient, Phase IIIb Extension Study to Assess Bone Turnover Recovery in Women With Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, and RVE1998080 (no NCT Study Numbers)
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) PopulationMean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Eligibility
Minimum age: N/A.
Maximum age: 85 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Post-menopausal women who sequentially completed studies RVE009093, RVE1996077,
RVE1998080
Exclusion Criteria:
- Less than 60% compliant between drug start and month 21
- Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements,
calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection >10,000
IU vitamin D, investigational drug
Locations and Contacts
Investigational Site, Hvidovre DK-2650, Denmark
Investigational Site, Oulu SF-90 100, Finland
Investigational Site, Siena I-53100, Italy
Investigational Site, Warsaw PL-02315, Poland
Investigational Site, Warszawa PL 03-0335, Poland
Investigational Site, Warszawa PL-04-736, Poland
Investigational Site, Warszawa PL00-909, Poland
Investigational Site, Barcelona 08907, Spain
Investigational Site, Madrid 28040, Spain
Investigational Site, Goteborg S-411 32, Sweden
Investigational Site, De Pintelaan 185, Gent B-9000, Belgium
Investigational Site, Concord, New South Wales 2139, Australia
Investigational Site, Parkville, Victoria 3052, Australia
Additional Information
Starting date: October 2001
Last updated: October 27, 2011
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