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Sponsors and Collaborators: |
University of California, Davis University of California, San Francisco |
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Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00221299 |
The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.
Condition | Intervention | Phase |
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Glucocorticoid Induced Osteoporosis |
Drug: Risedronate Drug: Parathyroid Hormone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Can Risedronate and Parathyroid Hormone Reverse Glucocorticoid Induced Osteoporosis? |
Estimated Enrollment: | 40 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | March 2008 |
Dr. Nancy Lane and colleagues at the University of California, Davis and University of California, San Francisco will be conducting this 2-year study of human parathyroid hormone (rhPTH 1-34) alone, and rhPTH (1-34) with risedronate compared to risedronate alone in men and women with osteopenia on chronic low dose glucocorticoids (GC). This is an investigator-initiated study funded by Aventis Pharmaceuticals.
The study will be divided into 2 phases. All study subjects will receive supplemental calcium citrate and Vitamin D during the 2-year study. In year one subjects will be randomly assigned to receive PTH (subcutaneously daily) or placebo and risedronate tablets or placebo. In year two, PTH will be stopped and subjects will be re-randomized to receive risedronate tablets or placebo.
Potential study subjects will have dual x-ray absorptiometry measurements (DEXA) of the spine and hip at the screening visit. Those study subjects who meet the inclusion criteria will be invited back for a baseline visit. DEXA scans of the spine, hip, and forearm will be done at Baseline visit, 6-month, 12-month, 18-month, and 24-month follow-up visits. DEXA scan of the spine, hip, and forearm takes approximately 20 minutes to complete. To assess incident vertebral and non-vertebral fractures, lateral thoracic and lumbar spine evaluation using Instant Vertebral Assessment [IVA] will be done at Baseline, 12-month, and 24-month follow-up visits.
The specific aims of the study are as follows:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Suzanne Schmitt | 916-734-2767 | suzanne.codoni-schmitt@ucdmc.ucdavis.edu |
Contact: Lisa Pastore | 916-734-2767 | lisa.pastore@ucdmc.ucdavis.edu |
United States, California | |
UC Davis General Medicine Research Clinic | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Lisa Pastore 916-734-2767 lisa.pastore@ucdmc.ucdavis.edu | |
Principal Investigator: John Robbins, MD, MHS | |
Principal Investigator: Nancy E Lane, MD |
Principal Investigator: | Nancy E Lane, MD | University of California, Davis |
Study ID Numbers: | RA-015865, IRB 200513216-1 |
Study First Received: | September 14, 2005 |
Last Updated: | September 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00221299 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Osteoporosis Steroids Prednisone |
Prednisone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Calcium Channel Blockers Bone Diseases, Metabolic Bone Density Conservation Agents |
Cardiovascular Agents Bone Diseases Hormones Glucocorticoids Calcium, Dietary Musculoskeletal Diseases Risedronic acid |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Calcium Channel Blockers Bone Diseases, Metabolic Bone Density Conservation Agents Cardiovascular Agents |
Bone Diseases Hormones Pharmacologic Actions Membrane Transport Modulators Musculoskeletal Diseases Therapeutic Uses Risedronic acid |