Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis
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|ClinicalTrials.gov Identifier: NCT00004993|
Recruitment Status : Completed
First Posted : March 20, 2000
Last Update Posted : March 2, 2010
Glucocorticoids are potent anti-inflammatory and immunosuppressive agents. However, prolonged use of these potent agents results in severe bone loss and osteoporotic fractures. Parathyroid hormone (1-34), when given as a daily injection has been found to dramatically increase bone mass in osteoporotic animals and postmenopausal women. The purpose of this study is to determine whether 2 years of daily PTH (1-34) injections will increase bone mass and reduce the development of new fractures. In addition, we will follow the study subjects for 2 more years to determine which type of anti-resorptive agent is required to maintain the newly formed bone.
We are enrolling postmenopausal women that are on chronic corticosteroid therapy (prednisone etc.) and have bone loss (osteopenia by DXA) to be a part of this four-year-long study. The patients will receive two-year therapy with either PTH (1-34) or placebo, and for the second part of the study subjects receive either estrogen and placebo or alendronate and placebo. We will measure bone gain by standard bone densitometry, special x-rays of the spine and hip, and serum and urine bone markers.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: Parathyroid hormone (hPTH 1-34)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Can PTH Reverse Glucocorticoid-induced Osteoporosis|
|Study Start Date :||August 1999|
|Study Completion Date :||August 2001|
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): NCT00004993
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Study Director:||Qaiser Rehman, M.D.||University of California at San Francisco|