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PTHrP and Osteoporosis

Pathophysiology of PTH-related Protein in Humans.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00021827
Enrollment
Unknown
Registered
2001-08-06
Start date
1999-06-30
Completion date
2001-12-31
Last updated
2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

parathyroid hormone-related protein, parathyroid hormone, anabolic skeletal therapy, postmenopausal women

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.

Interventions

DRUGParathyroid hormone-related protein or ''PTHrP''

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 75 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026