The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis

E. S. Orwoll, W. H. Scheele, S. Paul, S. Adami, U. Syversen, A. Diez-Perez, J. M. Kaufman, A. D. Clancy, G. A. Gaich

Research output: Contribution to journalArticle

583 Scopus citations

Abstract

Teriparatide [rhPTH(1-34)] increases bone mineral density and reduces the risk of vertebral fracture in women. We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 μg, or teriparatide 40 μg. All subjects also received supplemental calcium and vitamin D. The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies. Biochemical markers of bone formation increased early in the course of therapy and were followed by increases in indices of osteoclastic activity. Spine bone mineral density was greater than in placebo subjects after 3 months of teriparatide therapy, and by the end of therapy it was increased by 5.9% (20 μg) and 9.0% (40 μg) above baseline (p < 0.001 vs. placebo for both comparisons). Femoral neck bone mineral density increased 1.5% (20 μg; p = 0.029) and 2.9% (40 μg; p < 0.001), and whole body bone mineral content increased 0.6% (20 μg; p = 0.021) and 0.9% (40 μg; p = 0.005) above baseline in the teriparatide subjects. There was no change in radial bone mineral density in the teriparatide groups. Bone mineral density responses to teriparatide were similar regardless of gonadal status, age, baseline bone mineral density, body mass index, smoking, or alcohol intake. Subjects experienced expected changes in mineral metabolism. Adverse events were similar in the placebo and 20-μg groups, but more frequent in the 40-μg group. This study shows that teriparatide treatment results in an increase in bone mineral density and is a potentially useful therapy for osteoporosis in men.

Original languageEnglish (US)
Pages (from-to)9-17
Number of pages9
JournalJournal of Bone and Mineral Research
Volume18
Issue number1
DOIs
StatePublished - Jan 1 2003

    Fingerprint

Keywords

  • Bone density
  • Drug therapy
  • Men
  • Osteoporosis
  • Teriparatide

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Orthopedics and Sports Medicine

Cite this

Orwoll, E. S., Scheele, W. H., Paul, S., Adami, S., Syversen, U., Diez-Perez, A., Kaufman, J. M., Clancy, A. D., & Gaich, G. A. (2003). The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis. Journal of Bone and Mineral Research, 18(1), 9-17. https://doi.org/10.1359/jbmr.2003.18.1.9