Glucocorticoids Promote Osteoclast Survival
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|ClinicalTrials.gov Identifier: NCT00572299|
Recruitment Status : Terminated (Terminated due to recruitment problems)
First Posted : December 13, 2007
Last Update Posted : August 30, 2011
|Condition or disease||Intervention/treatment|
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.
- Liberman U, Weiss SR, Broll J, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 1995;333:1437-1443.
- Bone HG, Downs RW, Tucci JR, et al. Dose-response relationships for alendronate treatment in osteoporotic elderly women. J Clin Endocrinol Metab 1997;82:265-274.
- McClung M, Clemmesen B, Daifotis A, et al. Alendronate prevents postmenopausal bone loss in women without osteoporosis. Ann Intern Med 1998;128:253-261.
- Recker RR, Weinstein RS, Chestnut CH III, et al. Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporosis Int 2004;15:231-237.
- Saag KG, Emkey R, Schnitzer TJ, et al. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med 1998;339:292-299.
- Orwoll E, Ettinger M, Weiss S, et al. Alendronate for the treatment of osteoporosis in men. N Engl J Med 2000;343:604-610.
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|Official Title:||Glucocorticoids Promote Osteoclast Survival|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
patients receiving glucocorticoid treatment
glucocorticoids and bisphosphonates
patients receiving both glucocorticoids and bisphosphonates
70 mg of alendronate orally per week for at least three months in patients receiving at least 10 mg/day or oral prednisone for at least three months
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): NCT00572299
|United States, Arkansas|
|University of Arkansas hospitals and clinics and the Central Arkansas Veterans Healthcare System|
|Little Rock, Arkansas, United States, 72205|
|Study Chair:||Jimmie L Valentine||IRB at UAMS|