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Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis Clinical research trials and Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis. Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis clinical trial. Subjects often receive the most expert healthcare possible for their Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis  Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis
Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis
For Condition: Osteoporosis
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Postmenopausal women on glucocorticoids (prednisone 5mg/d or greater - Osteopenia by T score of hip or lumbar spine of -2.0 - All study subjects must be on a stable dose of estrogen/progesterone or raloxifene - Ambulatory and able to come to the clinical center 9 times over 2 years - Willing to sign an informed consent Exclusion Criteria: - Generalized disease of the bone (other than glucocorticoid-induced osteoporosis), including hyperparathyroidism, hyperthyroidism, Paget's disease) - Diseases that affect bone metabolism (e.g. alcoholism, inflammatory bowel disease, malabsorption, renal disease (Cr2) or liver disease (transaminase level 2 times limit of normal) - Within the past 1 year, regular use of medications that are known to affect bone metabolism (e.g. anabolic steroids, anticoagulants, anticonvulsants, pharmacologic doses of vitamin D and vitamin A supplements). - History of drug abuse - Senile dementia, paraplegia and/or quadriplegia - Unstable rheumatic disease with clinically significant renal or central nervous system involvement.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
QaiserRehman, Study Director, University of California at San Francisco
San Francisco General Hospital
San Francisco, California, 94110
United States
Additional Information:
Study ID Numbers: LANENE; DK46661
Study Start Date: August 1999
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004993
Other Osteoporosis Studies:
1. Osteoporosis Prevention After Heart Transplant
2. Encouraging Calcium Absorption and Bone Formation During Early Puberty
3. Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients with Prostate Cancer
4. Osteoporosis Prevention in Preadolescent Girls
5. Parathyroid Hormone (PTH) with Alendronate for Osteoporosis
Related Studies:
Other Osteoporosis Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis
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