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Can Parathyroid Hormone Injections Reverse Glucocorticoid-Induced Osteoporosis
This study has been completed.
Study NCT00004993   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First Received: March 17, 2000   Last Updated: June 23, 2005   History of Changes

March 17, 2000
June 23, 2005
August 1999
 
 
 
Complete list of historical versions of study NCT00004993 on ClinicalTrials.gov Archive Site
 
 
 
Can Parathyroid Hormone Injections Reverse Glucocorticoid-Induced Osteoporosis
Can PTH Reverse Glucocorticoid-Induced Osteoporosis

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.

 
Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control
Osteoporosis
Drug: Parathyroid hormone (hPTH 1-34)
 
Lane NE, Sanchez S, Modin GW, Genant HK, Pierini E, Arnaud CD. Parathyroid hormone treatment can reverse corticosteroid-induced osteoporosis. Results of a randomized controlled clinical trial. J Clin Invest. 1998 Oct 15;102(8):1627-33.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
August 2001
 

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.
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004993
 
LANENE, DK46661
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
Study Director: Qaiser Rehman, M.D. University of California at San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
July 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP