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

NCT ID: NCT00577421

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-01-31

Brief Summary

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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

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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)

Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

5 mg/day risedronate

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

5 mg tablet of risedronate once a day for 2 years

Interventions

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risedronate

5 mg tablet of risedronate once a day for 2 years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Can not use any bone modifying substances except risedronate
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dietrich H Wenderoth, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Research Site

Concord, , Australia

Site Status

Research Facility

Siena, , Italy

Site Status

Research Facility

Warsaw, , Poland

Site Status

Research Facility

Barcelona, , Spain

Site Status

Research Facility

Gothenburg, , Sweden

Site Status

Countries

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Australia Italy Poland Spain Sweden

Other Identifiers

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2002157

Identifier Type: -

Identifier Source: org_study_id