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Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

Primary Purpose

Postmenopausal Osteoporosis

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

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

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

Inclusion Criteria:

  • have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study)

Exclusion Criteria:

  • Can not use any bone modifying substances except risedronate

Sites / Locations

  • Research Site
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

5 mg/day risedronate

Outcomes

Primary Outcome Measures

To assess the safety and tolerability profile of 5 mg daily oral risedronate therapy administered for 2 years in patients with post-menopausal osteoporosis, who had received risedronate for 2 or 7 years and then had a risedronate-free year.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2007
Last Updated
September 27, 2011
Sponsor
Warner Chilcott
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00577421
Brief Title
Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO
Official Title
An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)
Detailed Description
A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
5 mg/day risedronate
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Description
5 mg tablet of risedronate once a day for 2 years
Primary Outcome Measure Information:
Title
To assess the safety and tolerability profile of 5 mg daily oral risedronate therapy administered for 2 years in patients with post-menopausal osteoporosis, who had received risedronate for 2 or 7 years and then had a risedronate-free year.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study) Exclusion Criteria: Can not use any bone modifying substances except risedronate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dietrich H Wenderoth, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Concord
Country
Australia
Facility Name
Research Facility
City
Sienna
Country
Italy
Facility Name
Research Facility
City
Warsaw
Country
Poland
Facility Name
Research Facility
City
Barcelona
Country
Spain
Facility Name
Research Facility
City
Goteborg
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

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