PTHrP and Osteoporosis
Pathophysiology of PTH-related Protein in Humans.
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
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Started Jun 1999
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
August 4, 2001
CompletedFirst Posted
Study publicly available on registry
August 6, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2001
CompletedMarch 2, 2010
March 1, 2010
August 4, 2001
March 1, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (3)
Plotkin H, Gundberg C, Mitnick M, Stewart AF. Dissociation of bone formation from resorption during 2-week treatment with human parathyroid hormone-related peptide-(1-36) in humans: potential as an anabolic therapy for osteoporosis. J Clin Endocrinol Metab. 1998 Aug;83(8):2786-91. doi: 10.1210/jcem.83.8.5047.
PMID: 9709948BACKGROUNDStewart AF, Cain RL, Burr DB, Jacob D, Turner CH, Hock JM. Six-month daily administration of parathyroid hormone and parathyroid hormone-related protein peptides to adult ovariectomized rats markedly enhances bone mass and biomechanical properties: a comparison of human parathyroid hormone 1-34, parathyroid hormone-related protein 1-36, and SDZ-parathyroid hormone 893. J Bone Miner Res. 2000 Aug;15(8):1517-25. doi: 10.1359/jbmr.2000.15.8.1517.
PMID: 10934650BACKGROUNDSyed MA, Horwitz MJ, Tedesco MB, Garcia-Ocana A, Wisniewski SR, Stewart AF. Parathyroid hormone-related protein-(1--36) stimulates renal tubular calcium reabsorption in normal human volunteers: implications for the pathogenesis of humoral hypercalcemia of malignancy. J Clin Endocrinol Metab. 2001 Apr;86(4):1525-31. doi: 10.1210/jcem.86.4.7406.
PMID: 11297578BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew F. Stewart
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 4, 2001
First Posted
August 6, 2001
Study Start
June 1, 1999
Study Completion
December 1, 2001
Last Updated
March 2, 2010
Record last verified: 2010-03