Effect of an intermittent weekly dose of human parathyroid hormone (1-34) on osteoporosis: a randomized double-masked prospective study using three dose levels

Osteoporos Int. 1999;9(4):296-306. doi: 10.1007/s001980050151.


To test the effect of amino-terminal peptide 1-34 of human parathyroid hormone (hPTH (1-34)) as a possible bone anabolic agent in the treatment of osteoporosis, weekly subcutaneous injection of 50 units (L group), 100 units (M group) or 200 units (H group) of hPTH (1-34) was started in 220 patients with osteoporosis at 71 institutions randomly divided into three groups in a double-masked system. Lumbar spine bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) increased by 0.6%, 3.6% and 8.1% after 48 weeks in groups L, M and H respectively, responses in groups M and H being significantly higher than in L (p<0.05, Mann-Whitney U-test). Since the coefficient of variation for lumbar spine measurement stayed at 1-2.5%, increases of 3.6% and 8.1% appeared significant. Metacarpal BMD and cortical thickness measured by radiogrammetry did not change significantly. Serum calcium decreased in each group and serum phosphorus decreased in groups M and H. Urinary calcium/creatinine decreased at the 12th week in group H and at the 24th and 48th weeks in groups M and L. Serum 25(OH) vitamin D and 1,25(OH)(2) vitamin D decreased in each group at the 48th week (p<0.05). Serum bone-type alkaline phosphatase was increased at the fourth week in groups H and M and decreased at the 48th week in group H. Urinary hydroxyproline, pyridinoline and deoxypyridinoline declined significantly in each group. Backache improved in 30-40% of each group. No serious adverse effects were found during the test period. Intermittent weekly injection of hPTH (1-34) increased lumbar BMD in osteoporosis, suggesting usefulness in the treatment of osteoporosis.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Biomarkers / blood
  • Biomarkers / urine
  • Bone Density / drug effects
  • Calcitriol / blood
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Humans
  • Middle Aged
  • Osteoporosis, Postmenopausal / drug therapy*
  • Osteoporosis, Postmenopausal / metabolism
  • Osteoporosis, Postmenopausal / physiopathology
  • Prospective Studies
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / therapeutic use
  • Teriparatide / administration & dosage*
  • Teriparatide / therapeutic use


  • Biomarkers
  • Recombinant Proteins
  • Teriparatide
  • Calcitriol