PTHrP and Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00021827
First received: August 4, 2001
Last updated: March 1, 2010
Last verified: March 2010

August 4, 2001
March 1, 2010
June 1999
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Complete list of historical versions of study NCT00021827 on ClinicalTrials.gov Archive Site
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PTHrP and Osteoporosis
Pathophysiology of PTH-related Protein in Humans.

PTH-related protein, or ''PTHrP'', is a hormone which was discovered in 1987. As its name implies, it is closely related to another hormone discovered in the 1920's named parathyroid hormone or ''PTH''. PTH has been shown to be effective in treating osteoporosis in both animals and humans. PTHrP has been shown to be effective in treating osteoporosis in laboratory animals, and there are strong scientific reasons to think that it may be effective in humans as well. However, no human trials with PTHrP in the treatment of osteoporosis have been performed. The studies in this trial are focussed on determining whether PTHrP can indeed increase bone mass in postmenopausal women with osteoporosis, when administered daily by subcutaneous injection for three months.

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Interventional
Phase 2
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Osteoporosis
Drug: Parathyroid hormone-related protein or ''PTHrP''
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2001
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Inclusion Criteria:

  • Healthy caucasian postmenopausal females between 50-75 years of age with low bone mineral density at the lumbar spine or hip as measured using dual energy x-ray absorptiometry or DXA.
  • ON estrogen replacement treatment for at least three years.

Exclusion Criteria:

  • Heart, vascular, kidney, liver, lung, hormonal, musculo-skeletal disease (other than osteoporosis), rheumatic, blood diseases are exclusion criteria.
  • High blood pressure
  • Pregnancy
  • Cancer
  • Alcohol or drug dependence
  • Prior use of a drug treatment for osteoporosis such as PTH, bisphosphonates, raloxifene, or calcitonin within the preceding five years
Female
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00021827
PTHrP and Osteo (completed), RO-1 DK 51081
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Andrew F. Stewart University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

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