3-Week Parathyroid Hormone-related Protein (PTHrP) Dose Escalation Study in Post-Menopausal Women

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

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 PTHrP has a skeletal 'anabolic' or bone-building effect, and has shown to increase bone mineral density in postmenopausal women with osteoporosis. Safety of PTHrP will be determined by measurements of blood pressure and pulse, serum blood calcium levels and subjective symptoms. Effectiveness will be measured by changes in measurements of blood and urine markers of bone turnover.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: Department of Health and Human Services; National Institutes of Health (NIH)
• Treatments: Hormones; Parathyroid Hormone; Parathyroid Hormone-Related Protein

Criteria

Inclusion Criteria:

• Women

• Caucasian

• Hispanic

• Asian

• One year past onset of menopause

• Weigh between 50 and 90 kilograms

Exclusion Criteria:

• 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)