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Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01249261
First received: November 24, 2010
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Postmenopausal Women With Osteoporosis
 Drug: Risedronate
Drug: Placebo/Risedronate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 12 (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 6 (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 12 (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 6 (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 12 (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 6 (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 12 (Year 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8) ] [ Designated as safety issue: No ]
    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).


Enrollment: 61
Study Start Date: October 2001
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249261

Locations
Australia, New South Wales
Investigational Site
Concord, New South Wales, Australia, 2139
Australia, Victoria
Investigational Site
Parkville, Victoria, Australia, 3052
Belgium
Investigational Site
De Pintelaan 185, Gent, Belgium, B-9000
Denmark
Investigational Site
Hvidovre, Denmark, DK-2650
Finland
Investigational Site
Oulu, Finland, SF-90 100
Italy
Investigational Site
Siena, Italy, I-53100
Poland
Investigational Site
Warsaw, Poland, PL-02315
Investigational Site
Warszawa, Poland, PL 03-0335
Investigational Site
Warszawa, Poland, PL-04-736
Investigational Site
Warszawa, Poland, PL00-909
Spain
Investigational Site
Barcelona, Spain, 08907
Investigational Site
Madrid, Spain, 28040
Sweden
Investigational Site
Goteborg, Sweden, S-411 32
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Warner Chilcott
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01249261     History of Changes
Other Study ID Numbers: 2001079
Study First Received: November 24, 2010
Results First Received: July 14, 2011
Last Updated: October 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Postmenopausal Women
Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Etidronic Acid
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013