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Published Online, 2 August 2005, www.theannals.com, DOI 10.1345/aph.1G146.
 The Annals of Pharmacotherapy: Vol. 39, No. 9, pp. 1511-1516. DOI 10.1345/aph.1G146
© 2005 Harvey Whitney Books Company.
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NEW DRUG DEVELOPMENTS

Parathyroid Hormone (1-84) and Treatment of Osteoporosis

Sarah P Shrader, PharmD

Family Medicine Pharmacy Resident, South Carolina College of Pharmacy, Charleston, SC

Kelly R Ragucci, PharmD BCPS CDE

Associate Professor, Pharmacy and Clinical Sciences/Family Medicine; Pharmacy Residency Program Director, Family Medicine, South Carolina College of Pharmacy

Reprints: Dr. Ragucci, South Carolina College of Pharmacy, 295 Calhoun St., PO Box 250192, Charleston, SC 29425-8904, fax 843/792-0436, raguccik{at}musc.edu

OBJECTIVE: To present the chemistry, pharmacology, and pharmacokinetics of parathyroid hormone (PTH) (1-84) and review the available clinical trials that evaluate its efficacy and safety; clinical applicability of this agent and its relationship to other Food and Drug Administration (FDA)-approved medications for treatment of osteoporosis are also discussed.

DATA SOURCES: A MEDLINE search (1996-December 2004) was completed, along with a review of information obtained from the manufacturer, NPS Pharmaceuticals. Key search terms included parathyroid hormone, PTH (1-84), and ALX 111.

STUDY SELECTION AND DATA EXTRACTION: Studies were selected based on their relevance and availability. Pertinent information, including objectives, design, demographics, outcomes, adverse events, dosing strategies, and therapeutic controversies, was extracted.

DATA SYNTHESIS: PTH (1-84) is being developed for treatment of osteoporosis. Recent studies have shown that, when administered intermittently as a subcutaneous injection, PTH (1-84) produces an increase in bone mineral density and prevents vertebral fractures. The fact that this agent contains the C-terminal region of PTH may differentiate it from PTH (1-34), teriparatide, which is approved by the FDA for treatment of osteoporosis. Further trials are necessary to determine the role of PTH (1-84) in combination with other treatments for osteoporosis and/or the order in which PTH (1-84) is given with these other agents. There are currently no comparative trials with other osteoporosis treatment modalities.

CONCLUSIONS: PTH (1-84), when given intermittently as a subcutaneous injection, appears to be a safe and efficacious treatment option for osteoporosis. Further trials are needed to determine its specific place in therapy compared with other treatment options.

Key Words: parathyroid hormone, PTH (1-84), teriparatide: osteoporosis

Published Online, August 2, 2005. www.theannals.com, DOI 10.1345/aph.1G146




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