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Can Parathyroid Hormone Injections Reverse Glucocorticoid-Induced Osteoporosis

This study has been completed.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00004993
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Parathyroid hormone (hPTH 1-34)
Phase II

MedlinePlus related topics:   Fractures    Osteoporosis   

ChemIDplus related topics:   Parathyroid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control
Official Title:   Can PTH Reverse Glucocorticoid-Induced Osteoporosis

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date:   August 1999
Estimated Study Completion Date:   August 2001

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004993

Locations
United States, California
San Francisco General Hospital    
      San Francisco, California, United States, 94110

Sponsors and Collaborators

Investigators
Study Director:     Qaiser Rehman, M.D.     University of California at San Francisco    
  More Information

Publications:

Study ID Numbers:   LANENE, DK46661
First Received:   March 17, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004993
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Parathyroid hormone (1-34)  
Glucocorticoid-induced osteoporosis  
Postmenopausal women  
osteoporotic fractures  

Study placed in the following topic categories:
Musculoskeletal Diseases
Fractures, Bone
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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