Phase 3 N=61 Randomized Treatment

Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

Postmenopausal Women With Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT01249261 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Oct 2011

Primary outcome: Primary: Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population — 6.2217; 12.7784 Percent Change

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Risedronate (Drug); Placebo/Risedronate (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Warner Chilcott
Primary completion: May 2003

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population	6.2217; 12.7784	—
PRIMARY Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population	5.5312; 13.3472	—
PRIMARY Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	5.5312; 13.3472	—
PRIMARY Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population	-1.0384; 1.4797	—
PRIMARY Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population	-0.2530; 3.2192	—
PRIMARY Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	-1.1148; 3.2192	—
PRIMARY Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population	1.6386; 4.4060	—
PRIMARY Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population	1.9561; 2.2334	—
PRIMARY Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	1.4058; 2.2334	—
PRIMARY Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population	-1.3867; 3.3871	—
PRIMARY Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population	-2.2999; 0.6672	—
PRIMARY Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	-3.2799; 0.6672	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01249261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.