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First published online on March 15, 2005
Endocrine Reviews, doi:10.1210/er.2004-0006
Endocrine Reviews, doi:10.1210/er.2004-0006
Endocrine Reviews 0 (2005): 200400061-
Copyright © 2005 by The Endocrine Society
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*PARATHYROID HORMONE

PARATHYROID HORMONE AND TERIPARATIDE FOR THE TREATMENT OF OSTEOPOROSIS: A REVIEW OF THE EVIDENCE AND SUGGESTED GUIDELINES FOR ITS USE

Anthony B. Hodsman*, Douglas C. Bauer, David Dempster, Larry Dian, David A. Hanley, Steven T. Harris, David Kendler, Michael R. McClung, Paul D. Miller, Wojciech P. Olszynski, Eric Orwoll, and Chui Kin Yuen

Epidemiology, and Biostatistics, Director of Research, Division of Medicine, University of California, San Francisco, California; Columbia University, New York, Director, Regional Bone Center, Helen Hayes hospital, West Haverstraw, NY 10993; Division of Geriatric Medicine, University of British Columbia, Vancouver, British Columbia, Canada V6T 2B5; Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine, University of Calgary, Calgary, Alberta; Chief, Osteoporosis Clinic, University of California, San Francisco, California; Department of Medicine (Endocrinology), Director, Osteoporosis Research Centre, University of British Columbia, Vancouver, British Columbia; Department of Medical Education, Providence Portland Medical Center, Portland, Oregon; University of Colorado Medical School, Medical Director, Colorado Center for Bone Research, Lakewood, Colorado; University of Saskatchewan, Director, Saskatoon Osteoporosis Centre, Saskatoon, Saskatchewan; General Clinical Research Centre, Oregon Health and Sciences University; Dep of Obstetrics, Gynaecology and Reproductive Sciences, Dept of Continuing Medical Education, University of Manitoba, Chairman, Manitoba Clinic, Winnipeg, Manitoba

* To whom correspondence should be addressed. E-mail: anthony.hodsman{at}sjhc.london.on.ca.

All therapies currently recommended for the management of osteoporosis act mainly to inhibit bone resorption and reduce bone remodeling. PTH and its analog, teriparatide (recombinant human PTH (1-34), represent a new class of anabolic therapies for the treatment of severe osteoporosis, having the potential to improve skeletal micro-architecture. Significant reductions in both vertebral and appendicular fracture rates have been demonstrated in the phase 3 trial of teriparatide, involving elderly women with at least 1 prevalent vertebral fracture before the onset of therapy. However there is as yet no evidence that the anti-fracture efficacy of PTH will be superior to the bisphosphonates, while cost-utility estimates suggest that teriparatide is significantly more expensive.

Teriparatide should be considered as treatment for post-menopausal women and men with severe osteoporosis, as well as for patients with established glucocorticoid-induced osteoporosis who require long-term steroid treatment. Teriparatide should also be considered for the management of individuals at particularly high risk for fractures, including subjects who are younger than age 65 and who have particularly low BMD measurements (T-scores ≤3.5). Teriparatide therapy is not recommended beyond 2 yr, in part based on the induction of osteosarcoma in a rat model of carcinogenicity.

Total daily calcium intake from both supplements and dietary sources should be limited to 1500 mg together with adequate vitamin D intake (up to 1000 U/day). Monitoring of serum calcium may be safely limited to measurement after one month of treatment; mild hypercalcemia may be treated by either withdrawing dietary calcium supplements, reducing the dosing frequency of PTH, or both. At present, concurrent therapy with anti-resorptive therapy, particularly bisphosphonates should be avoided, although sequential therapy with such agents may consolidate the beneficial effects upon the skeleton after PTH is discontinued.


Key words: Parathyroid hormone • teriparatide • osteoporosis • fracture • treatment




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