Efficacy and safety of human parathyroid hormone-(1-84) in increasing bone mineral density in postmenopausal osteoporosis

J Clin Endocrinol Metab. 2003 Nov;88(11):5212-20. doi: 10.1210/jc.2003-030768.


Daily sc injections of N-terminal analogs of PTH increase bone mass and decrease fractures in osteoporotic women. We investigated the efficacy and safety of human PTH-(1-84) (full-length PTH) in the treatment of postmenopausal osteoporosis in a double-blind, placebo-controlled study. The women (n = 50-53/group) self-administered PTH (50, 75, or 100 microg) or placebo by daily sc injection for 12 months. PTH treatment induced time- and dose-related increases in lumbar spine bone mineral density (BMD). The 100-microg dose increased BMD significantly at 3 months (+2.0%) and 12 months (+7.8%). BMD underestimated the anabolic effect of PTH in lumbar spine (bone mineral content, +10.0%) because bone area increased significantly (+2.0%). A nonsignificant decrease (-0.9%) in total hip BMD occurred during the first 6 months with the 100-microg dose, but this trend reversed (+1.6%) during the second 6 months. Bone turnover markers increased during the first half of the study and were maintained at elevated levels during the second 6 months. Protocol compliance was excellent (95-98%), and treatment was generally safe and well tolerated. Dose-related incidences of transient hypercalcemia occurred, but only one patient (100-microg group) was withdrawn because of repeated hypercalcemia. Thus, full-length PTH was efficacious and safe over 12 months.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Absorptiometry, Photon
  • Aged
  • Biomarkers
  • Bone Density / drug effects*
  • Calcium / blood
  • Calcium / urine
  • Female
  • Femur Neck / metabolism
  • Hip Joint
  • Humans
  • Lumbar Vertebrae / metabolism
  • Middle Aged
  • Osteoporosis, Postmenopausal / drug therapy*
  • Parathyroid Hormone / administration & dosage*
  • Parathyroid Hormone / adverse effects
  • Prospective Studies


  • Biomarkers
  • Parathyroid Hormone
  • Calcium