Status:
COMPLETED
3-Week Parathyroid Hormone-related Protein (PTHrP) Dose Escalation Study in Post-Menopausal Women
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institutes of Health (NIH)
Department of Health and Human Services
Conditions:
Osteoporosis
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
50-75 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to determine the safety and effectiveness of three week daily subcutaneous injections of Parathyroid Hormone-related Protein (1-36). Previous studies indicated that P...
Detailed Description
Parathyroid Hormone-related Protein (1-36) or PTHrP is a neuroendocrine peptide which shares significant homology with the only currently FDA approved anabolic agent for the treatment of osteoporosis:...
Eligibility Criteria
Inclusion
- Women
- Caucasian
- Hispanic
- Asian
- One year past onset of menopause
- Weigh between 50 and 90 kilograms
Exclusion
- Taking bisphosphonates in the last 2 years
- Estrogen replacement hormones in last year
- SERMS in last year
- One weeks worth of PTHrP, PTH or an analog of PTH in past year
- Recent non-traumatic bone fracture within last year
- Significant uncontrolled cardiac, vascular, renal, pulmonary, endocrine or rheumatologic disease
- History of malignancy
- Anemia
- Significant alcohol or drug abuse
- Receiving any investigational drug within past 90 days
- Medications that interfere with metabolism or renal clearance of study drug, oral or systemic glucocorticoids of \> 5 mg/day prednisone (or equivalent) over the past year
- Thiazide-type diuretics
- Abnormal screening labs (calcium, vit D and PTH, CBC)
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00222872
Start Date
July 1 2005
End Date
September 1 2008
Last Update
April 28 2014
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213