Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Postmenopausal Women With Osteoporosis

Intervention / Treatment
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* Drug: Risedronate
* Drug: Placebo/Risedronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo/Risedronate<br>Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8 | Drug: Placebo/Risedronate<br>* placebo years 1-5 followed by 5 mg risedronate years 6 & 7 and no drug year 8<br>|
| Active Comparator: Risedronate<br>Risedronate 5mg years 1-7, no drug year 8 | Drug: Risedronate<br>* 5 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population | 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). | Baseline Core Study (Year 1) to Month 6 (Year 8) | 
| Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population | 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). | Baseline Core Study (Year 1) to Month 12 (Year 8) | 
| Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 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). | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) | 
| Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population | 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). | Baseline Core Study (Year 1) to Month 6 (Year 8) | 
| Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population | 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). | Baseline Core Study (Year 1) to Month 12 (Year 8) | 
| Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 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). | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) | 
| Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population | 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). | Baseline Core Study (Year 1) to Month 6 (Year 8) | 
| Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population | 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). | Baseline Core Study (Year 1) to Month 12 (Year 8) | 
| Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 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). | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) | 
| Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population | 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). | Baseline Core Study (Year 1) to Month 6 (Year 8) | 
| Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population | 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). | Baseline Core Study (Year 1) to Month 12 (Year 8) | 
| Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population | 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). | Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal Women, Osteoporosis