PTHrP and Osteoporosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: Parathyroid hormone-related protein or ''PTHrP''	Phase II

MedlinePlus related topics:

Osteoporosis

ChemIDplus related topics:

Parathyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Official Title:	Pathophysiology of PTH-Related Protein in Humans.

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

Study Start Date:	June 1999
Estimated Study Completion Date:	December 2001

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021827

Locations


United States, Pennsylvania
	University of Pittsburgh School of Medicine
	Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

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

Investigators


Principal Investigator:	Andrew F. Stewart	University of Pittsburgh

More Information

Publications:

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.

Stewart 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.

Syed 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.

Study ID Numbers:	PTHrP and Osteo, RO-1 DK 51081
First Received:	August 4, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00021827
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

parathyroid hormone-related protein

parathyroid hormone

anabolic skeletal therapy

postmenopausal women

Study placed in the following topic categories:

Musculoskeletal Diseases

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

ClinicalTrials.gov processed this record on October 10, 2008

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:	NCT00021827