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Comparison Study of PTHrP and PTH to Treat Osteoporosis

Sponsored by University of Pittsburgh

Phase Quota
Phase 2

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). 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.

Study Start Date: May 2009

Estimated Completion Date: June 2012

Specialties: Obstetrics & Gynecology: Menopausal Medicine Endocrinology: Bone Metabolism,Thyroid/Parathyroid Rheumatology: Bone Metabolism Orthopedics: Bone Metabolism Physician Assistant: Obstetrics/Gynecology,Orthopedics

Interventions

  • Drug: Parathyroid hormone related protein (1-36)
  • Drug: Parathyroid hormone related protein(1-36)
  • Drug: Parathyroid hormone (1-34)

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 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

Study Locations And Contact Information

  • UPMC Clinical Translational Research Center, Pittsburgh Pennsylvania
  • UPMC Clinical & Translational Research Center, Pittsburgh Pennsylvania

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