Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

Phase 3

Completed

• Conditions: Postmenopausal Women With Osteoporosis
• Interventions: Drug: Placebo/Risedronate; Drug: Risedronate

• Registration Number: NCT01249261
• Lead Sponsor: Warner Chilcott

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-29
• Results First Submitted: 2011-07-14
• Results First Submitted QC: 2011-09-15
• Status Verified: 2011-10
• Results First Posted: 2011-10-26
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/Risedronate	Placebo/Risedronate	Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
Risedronate	Risedronate	Risedronate 5mg years 1-7, no drug year 8

Primary Outcome Measures

Name	Time	Method
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population	Baseline Core Study (Year 1) to Month 6 (Year 8)	Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population	Baseline Core Study (Year 1) to Month 12 (Year 8)	Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)	Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population	Baseline Core Study (Year 1) to Month 6 (Year 8)	Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population	Baseline Core Study (Year 1) to Month 12 (Year 8)	Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)	Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population	Baseline Core Study (Year 1) to Month 6 (Year 8)	Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population	Baseline Core Study (Year 1) to Month 12 (Year 8)	Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)	Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population	Baseline Core Study (Year 1) to Month 6 (Year 8)	Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population	Baseline Core Study (Year 1) to Month 12 (Year 8)	Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)	Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).

Trial Locations

Locations (1)

Investigational Site; 🇸🇪 Goteborg, Sweden