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NCT00577421 Clinical Trial

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

Postmenopausal Osteoporosis Clinical Trial

Official title:
An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00577421
Other study ID # 2002157
Secondary ID
Status Completed
Phase Phase 3
First received December 19, 2007
Last updated September 27, 2011
Start date June 2003
Est. completion date January 2006

Study information
Verified date September 2011
Source Warner Chilcott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 55 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Can not use any bone modifying substances except risedronate

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• risedronate
5 mg tablet of risedronate once a day for 2 years

Locations
Country Name City State
Australia Research Site Concord
Italy Research Facility Sienna
Poland Research Facility Warsaw
Spain Research Facility Barcelona
Sweden Research Facility Goteborg

Sponsors (2)
Lead Sponsor Collaborator
Warner Chilcott Sanofi

Countries where clinical trial is conducted

Australia,  Italy,  Poland,  Spain,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2 years Yes
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Completed NCT00541658 - A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis Phase 3
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Active, not recruiting NCT03720886 - G56W1 in Women With Postmenopausal Osteoporosis Phase 1/Phase 2
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