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

Sponsors and Collaborators:	Procter and Gamble Sanofi-Aventis
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00577421

Purpose

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

Condition	Intervention	Phase
Postmenopausal Osteoporosis	Drug: risedronate	Phase III

MedlinePlus related topics: Osteoporosis

Drug Information available for: Risedronate sodium Risedronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

Further study details as provided by Procter and Gamble:

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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	32
Study Start Date:	June 2003
Study Completion Date:	January 2006

Arms	Assigned Interventions
1: Experimental 5 mg/day risedronate	Drug: risedronate 5 mg tablet of risedronate once a day for 2 years

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

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Can not use any bone modifying substances except risedronate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577421

Locations

Australia
Research Site
Concord, Australia
Italy
Research Facility
Sienna, Italy
Poland
Research Facility
Warsaw, Poland
Spain
Research Facility
Barcelona, Spain
Sweden
Research Facility
Goteborg, Sweden

Sponsors and Collaborators

Procter and Gamble

Sanofi-Aventis

Investigators

Study Director:

Dietrich H Wenderoth, MD

Procter and Gamble

More Information

Responsible Party:	Procter & Gamble ( Dietrich Wenderoth, MD )
Study ID Numbers:	2002157
Study First Received:	December 19, 2007
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00577421
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis

Bone Diseases, Metabolic
Bone Diseases
Risedronic acid

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Calcium Channel Blockers
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009