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Sponsors and Collaborators: |
Procter and Gamble Sanofi-Aventis |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00577837 |
A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.
Condition | Intervention | Phase |
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Postmenopausal |
Drug: risedronate Drug: experimental |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Active-Controlled, Double-Blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly in Postmenopausal Women With Low Bone Mineral Density |
Enrollment: | 370 |
Study Start Date: | April 2004 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
5 mg risedronate, once daily for 6 months
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Drug: risedronate
tablet, 5 mg risedronate daily for 6 months
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2: Experimental
100 mg risedronate, once a month for 6 months
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Drug: risedronate
tablet, 100 mg risedronate monthly for 6 months
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3: Experimental
150 mg risedronate, once a month for 6 months
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Drug: risedronate
tablet, 150 mg risedronate monthly for 6 months
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4: Experimental
200 mg risedronate, once a month for 6 months
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Drug: experimental
tablet, 200 mg risedronate monthly for 6 months
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Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug:
United States, Florida | |
Research Site | |
Gainesville, Florida, United States | |
Research Site | |
Daytona Beach, Florida, United States | |
United States, Kansas | |
Research Site | |
Shawnee Mission, Kansas, United States | |
United States, Texas | |
Research Site | |
San Antonio, Texas, United States | |
Canada, Ontario | |
Research Site | |
Hamilton, Ontario, Canada | |
Canada, Quebec | |
Research Facility | |
Sainte-Foy, Quebec, Canada | |
Research Facility | |
Montreal, Quebec, Canada | |
Croatia | |
Research Facility | |
Zagreb, Croatia | |
Netherlands | |
Research Facility | |
Leiden, Netherlands | |
Research Facility | |
Amsterdam, Netherlands | |
Poland | |
Research Facility | |
Bialystok, Poland | |
Research Site | |
Wroclaw, Poland | |
Research Site | |
Lublin, Poland | |
Research Site | |
Warszawa, Poland |
Study Director: | John Beary, MD | Procter and Gamble |
Responsible Party: | Proctor and Gamble ( Dietrich H Wenderoth, MD ) |
Study ID Numbers: | 2003134, HMR4003K/2001 |
Study First Received: | December 19, 2007 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00577837 |
Health Authority: | United States: Food and Drug Administration |
Calcium, Dietary Risedronic acid |
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 |