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Sponsors and Collaborators: |
Sanofi-Aventis Procter and Gamble |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00130403 |
To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.
Condition | Intervention | Phase |
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Osteoporosis, Postmenopausal |
Drug: risedronate sodium |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide |
Enrollment: | 290 |
Study Start Date: | March 2004 |
Study Completion Date: | March 2007 |
All subjects will be treated with teriparatide (human, recombinant PTH[1-34])(human, recombinant PTH[1-34]), 20 microgram subcutaneously daily for 12 months. Subjects will consist of 290 postmenopausal women previously treated with either risedronate or alendronate for at least 24 months. An approximately equal number of subjects will have been previously treated with risedronate and alendronate, and the subjects will be balanced with regard to duration of previous treatment.
Ages Eligible for Study: | 55 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
ELIGIBILITY CRITERIA include:
EXCLUSION CRITERIA include:
United States, New Jersey | |
sanofi-aventis, US | |
Bridgewater, New Jersey, United States, 08807 | |
Australia, New South Wales | |
sanofi-aventis, Australia | |
Cove, New South Wales, Australia | |
Belgium | |
sanofi-aventis, Belgium | |
Diegem, Belgium | |
Canada, Quebec | |
sanofi-aventis, Canada | |
Laval, Quebec, Canada | |
France | |
sanofi-aventis, France | |
Paris, France | |
Netherlands | |
sanofi-aventis, Netherlands | |
Gouda, Netherlands | |
United Kingdom, Surrey | |
sanofi-aventi, UK | |
Guildford, Surrey, United Kingdom |
Study Director: | Suzanne Meeves, PharmD, MBA | Sanofi-Aventis |
Study ID Numbers: | HMR4003B/4034, EudraCT # :2004-002317-37 |
Study First Received: | August 12, 2005 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00130403 |
Health Authority: | United States: Institutional Review Board |
Calcium, Dietary Musculoskeletal Diseases Teriparatide Alendronate Osteoporosis, Postmenopausal |
Osteoporosis Bone Diseases, Metabolic Bone Diseases 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 |