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Completed

NCT Number: NCT01249261

Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

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.

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Key information

Conditions

Postmenopausal Women With Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

Up to 85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Concord, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risedronate

Drug

5 mg/day

Placebo/Risedronate

Drug

placebo years 1-5 followed by 5 mg risedronate years 6 & 7 and no drug year 8

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study 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)

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Nov 29, 2010
Registry last updated
Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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