Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

October 27, 2011 updated by: Warner Chilcott

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Investigational Site
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Investigational Site
  • Belgium
    • Gent
      • De Pintelaan 185, Gent, Belgium, B-9000
        • Investigational Site
  • Denmark
      • Hvidovre, Denmark, DK-2650
        • Investigational Site
  • Finland
      • Oulu, Finland, SF-90 100
        • Investigational Site
  • Italy
      • Siena, Italy, I-53100
        • Investigational Site
  • Poland
      • Warsaw, Poland, PL-02315
        • Investigational Site
      • Warszawa, Poland, PL 03-0335
        • Investigational Site
      • Warszawa, Poland, PL-04-736
        • Investigational Site
      • Warszawa, Poland, PL00-909
        • Investigational Site
  • Spain
      • Barcelona, Spain, 08907
        • Investigational Site
      • Madrid, Spain, 28040
        • Investigational Site
  • Sweden
      • Goteborg, Sweden, S-411 32
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Investigators

  • Study Director: Herman Ellman, MD, Warner Chilcott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 29, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2011

Last Update Submitted That Met QC Criteria

October 27, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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