PTHrP and Osteoporosis

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: Parathyroid hormone-related protein or ''PTHrP''

Study type: Interventional

Funder types: NIH

Identifiers

NCT00021827

RO-1 DK 51081

PTHrP and Osteo (completed)

Details and patient eligibility

About

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.

Sex: Female

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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