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Sponsored by: |
University of Arkansas |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00572299 |
The purpose of this study is to determine the difference in response to bisphosphonate therapy in patients receiving excess glucocorticoids compared to patients with postmenopausal or male osteoporosis. Bisphosphonates are approved by the FDA for the treatment of postmenopausal women and osteoporotic men who are at high risk of fracture and in men and women with excess glucocorticoid administration.
Condition |
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Postmenopausal Osteoporosis Male Osteoporosis |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Glucocorticoids Promote Osteoclast Survival |
bone biopsy specimens
Estimated Enrollment: | 60 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | March 2009 |
Groups/Cohorts |
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1 |
2 |
Aminobisphosphonates are extensively used to prevent fractures in patients with osteoporosis (1-6). Treatment with these drugs leads to decreases in bone resorption and biochemical markers of bone turnover and progressive increases in bone mineral density (BMD). The increase in BMD in response to bisphosphonate therapy in glucocorticoid-treated patients is, however, less than half that measured in women and men with osteoporosis unrelated to glucocorticoid drugs even though the patients with osteoporosis are usually older. The goal of this objective is to determine the contribution of increased osteoclast survival to the diminished response to bisphosphonate therapy in patients receiving excess glucocorticoids compared to patients with osteoporosis.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
adults receiving aminobisphosphonate therapy to prevent osteoporosis from glucocorticoids, postmenopausal bone loss or osteoporosis in males
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert S Weinstein, M.D. | 501-686-5130 | weinsteinroberts@uams.edu |
United States, Arkansas | |
University of Arkansas hospitals and clinics and the Central Arkansas Veterans Healthcare System | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Robert S Weinstein, M.D. 501-686-5130 weinsteinroberts@uams.edu | |
Principal Investigator: Robert S Weinstein, M.D. |
Study Chair: | Jimmie L Valentine | IRB at UAMS |
Responsible Party: | University of Arkansas for Medical Sciences ( Robert S. Weinstein, M.D. ) |
Study ID Numbers: | 28727, VA Merit Review Grant |
Study First Received: | December 11, 2007 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00572299 History of Changes |
Health Authority: | United States: Institutional Review Board |
glucocorticoids, prednisone, alendronate,osteoclasts |
Prednisone Musculoskeletal Diseases Alendronate Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis, Postmenopausal |
Osteoporosis Bone Diseases, Metabolic Hormones Glucocorticoids Bone Diseases |
Musculoskeletal Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis, Postmenopausal Osteoporosis |
Bone Diseases, Metabolic Hormones Glucocorticoids Bone Diseases Pharmacologic Actions |