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Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

Primary Purpose

Postmenopausal Women With Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risedronate
Placebo/Risedronate
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Women With Osteoporosis focused on measuring Postmenopausal Women, Osteoporosis

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo/Risedronate

Risedronate

Arm Description

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

Risedronate 5mg years 1-7, no drug year 8

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
November 24, 2010
Last Updated
October 27, 2011
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT01249261
Brief Title
Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Women With Osteoporosis
Keywords
Postmenopausal Women, Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo/Risedronate
Arm Type
Placebo Comparator
Arm Description
Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
Arm Title
Risedronate
Arm Type
Active Comparator
Arm Description
Risedronate 5mg years 1-7, no drug year 8
Intervention Type
Drug
Intervention Name(s)
Risedronate
Intervention Description
5 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo/Risedronate
Intervention Description
placebo years 1-5 followed by 5 mg risedronate years 6 & 7 and no drug year 8
Primary Outcome Measure Information:
Title
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 6 (Year 8)
Title
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 12 (Year 8)
Title
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Title
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 6 (Year 8)
Title
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 12 (Year 8)
Title
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Title
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 6 (Year 8)
Title
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 12 (Year 8)
Title
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Title
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 6 (Year 8)
Title
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 12 (Year 8)
Title
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Description
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).
Time Frame
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman Ellman, MD
Organizational Affiliation
Warner Chilcott
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Investigational Site
City
De Pintelaan 185
State/Province
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Investigational Site
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
Facility Name
Investigational Site
City
Oulu
ZIP/Postal Code
SF-90 100
Country
Finland
Facility Name
Investigational Site
City
Siena
ZIP/Postal Code
I-53100
Country
Italy
Facility Name
Investigational Site
City
Warsaw
ZIP/Postal Code
PL-02315
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
PL 03-0335
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
PL-04-736
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
PL00-909
Country
Poland
Facility Name
Investigational Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site
City
Goteborg
ZIP/Postal Code
S-411 32
Country
Sweden

12. IPD Sharing Statement

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Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

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