Comparison Study of PTHrP and PTH to Treat Osteoporosis

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

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 demonstrate that daily subcutaneous injection of PTHrP (1-36) in postmenopausal women with osteoporosis stimulates bone formation to the same or greater degree than PTH (1-34) but with less bone resorption.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Treatments: Hormones; Parathyroid Hormone; Parathyroid Hormone-Related Protein; Teriparatide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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