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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) Population

Mean 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

Page last updated: August 20, 2015

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