Status:
COMPLETED
Comparison Study of PTHrP and PTH to Treat Osteoporosis
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Osteoporosis
Eligibility:
FEMALE
45-75 years
Phase:
PHASE2
Brief Summary
This is a three month comparison trial of standard dose parathyroid hormone (PTH) (1-34) and two different doses of Parathyroid Hormone-related Protein (PTHrP) (1-36). The investigators want to to dem...
Detailed Description
Osteoporosis is a metabolic bone disease characterized by low bone mass and structural deterioration of bone tissue. It results from failure of osteoblasts to form sufficient new bone, from an excessi...
Eligibility Criteria
Inclusion
- 45 - 75 year old Caucasian, Hispanic or Asian women
- one year post-menopausal if older than 50 years
- three years post-menopausal if between the ages of 45 - 50 years
- body mass index less than or equal to 30
- T-scores on screening Dual X-Ray Absorbiometry (DXA) scan between - 2.0 to - 4.5 of lumbar spine or hip
- have at lease two spinal vertebrae evaluable by DXA analysis
Exclusion
- bisphosphonate therapy within the last two years
- estrogen replacement hormones or SERMS within last one year
- no more than one week of PTHrP, PTH, or an analog of PTH within the last year
- an atraumatic bone fracture within the last 6 months
- significant or active diseases of any organ system
- history of malignancy
- anemia with a hematocrit less than 34%
- significant drug or alcohol abuse
- having received any investigational drug within the last 90 days
- taking any medication that may interfere with skeletal metabolism, such as phenobarbital, dilantin, glucocorticoids, and hydrochlorathiazide
- abnormal screening labs including serum Ca greater than 10.5 g/dl, 25 hydroxy vitamin D less than 20 ng/ml or PTH greater than 65 pg/ml
- African-Americans for this particular study - although future studies are planned
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00853723
Start Date
May 1 2009
End Date
June 1 2012
Last Update
March 24 2016
Active Locations (1)
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1
UPMC Clinical & Translational Research Center
Pittsburgh, Pennsylvania, United States, 15213