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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00577421
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : September 28, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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)

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: risedronate Phase 3

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)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO
Study Start Date : June 2003
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
5 mg/day risedronate
Drug: risedronate
5 mg tablet of risedronate once a day for 2 years


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Warner Chilcott
Sanofi
Investigators
Study Director: Dietrich H Wenderoth, MD Procter and Gamble
More Information

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00577421     History of Changes
Other Study ID Numbers: 2002157
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs