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PTHrP and Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Parathyroid hormone-related protein or ''PTHrP''
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring parathyroid hormone-related protein, parathyroid hormone, anabolic skeletal therapy, postmenopausal women

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Pittsburgh School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 4, 2001
Last Updated
March 1, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00021827
Brief Title
PTHrP and Osteoporosis
Official Title
Pathophysiology of PTH-related Protein in Humans.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
parathyroid hormone-related protein, parathyroid hormone, anabolic skeletal therapy, postmenopausal women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Parathyroid hormone-related protein or ''PTHrP''

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew F. Stewart
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9709948
Citation
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.
Results Reference
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PubMed Identifier
10934650
Citation
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. doi: 10.1359/jbmr.2000.15.8.1517.
Results Reference
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PubMed Identifier
11297578
Citation
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. doi: 10.1210/jcem.86.4.7406.
Results Reference
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PTHrP and Osteoporosis

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