Status:
WITHDRAWN
"PTHrP(1-36) IV Dose Escalation Study"
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Osteoporosis
Eligibility:
All Genders
24-35 years
Phase:
PHASE1
Brief Summary
This is a single-blinded, one-treatment, combination dose escalation and pharmacokinetic study done in healthy volunteers. The investigators want to determine whether Parathyroid Hormone related Prote...
Detailed Description
Osteoporosis is a growing health problem. The most commonly used treatment options are anti-resorptive agents, which give a bone density increase of the lumbar spine in the 6-8% range over a 3-5 year ...
Eligibility Criteria
Inclusion
- Healthy Caucasian subjects of both sexes between the ages of 24-35 years -
Exclusion
- Pregnancy Subjects with cardiac, hypertension, vascular, renal, pulmonary, endocrine, musculoskeletal, hepatic hematologic or malignant or rheumatologic disease.
- Body Mass Index greater than 30 anemia (hematocrit less than 36% in women, less than 40% in men) significant alcohol or drug abuse, baseline hypotension (systolic blood pressure less than 90 mm/HG) baseline hypertension (systolic BP greater than 140 mmHg or diastolic BP greater than 90 mmHg Abnormal screening labs including: ionized and total serum calcium, phosphorus, creatinine, albumin, 25-hydroxyvitamin D, and PTH.
- Subjects taking any chronic medication except oral contraceptives Those who have received an investigational drug in the past 90 days Any subject who has previously received either PTH or PTHrP African Americans and other ethnic minorities will be excluded since it is well documented that osteoporosis is far more common in Caucasians than in African-Americans, and there are clear quantitative differences in bone density and sensitivity to parathyroid hormone between African-Americans and Caucasians. -
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00177411
Start Date
July 1 2005
End Date
July 1 2007
Last Update
September 5 2014
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213