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FORMULARY FORUM

Teriparatide for Severe Osteoporosis

Assistant Professor, Department of Pharmacy and the Geriatric Pharmacotherapy Program, School of Pharmacy, Virginia Commonwealth University, Richmond, VA

Jeffrey C Delafuente, MS FCCP FASCP

Professor and Director of Geriatric Programs, Department of Pharmacy and the Geriatric Pharmacotherapy Program, School of Pharmacy, Virginia Commonwealth University

Reprints: Kimberly A Cappuzzo PharmD MS, Virginia Commonwealth University, 410 N. 12th St., Rm. 454, PO Box 980533, Richmond, VA 23298-0533, fax 804/828-8359, kacappuzzo{at}vcu.edu

OBJECTIVE: To review the pharmacology, toxicology, pharmacokinetics, pharmacodynamics, efficacy, safety, therapeutic controversies, administration, patient counseling, and formulary recommendations for teriparatide (rDNA origin).

DATA SOURCES: A MEDLINE search (1966–May 2003) of articles using the key words parathyroid hormone and osteoporosis, parathyroid hormone and fracture, and teriparatide was conducted to identify relevant literature in the English language. Additional references were obtained from bibliographies of those articles. Some clinical trial data not yet published were obtained from the manufacturer.

STUDY SELECTION AND DATA EXTRACTION: All articles obtained from the data sources were reviewed; all data deemed relevant were included.

DATA SYNTHESIS: Teriparatide, recombinant human parathyroid hormone (1-34) [rhPTH (1-34)], is the first anabolic agent to treat postmenopausal women with osteoporosis and men with idiopathic or hypogonadal osteoporosis who are at high risk for osteoporotic fracture. Daily subcutaneous injections of teriparatide significantly increase both spine and hip bone-mineral density (BMD) while decreasing the incidence of fractures in both women and men. Common adverse effects noted with teriparatide use were nausea, headache, dizziness, and arthralgias. An increased incidence of osteosarcoma in rats during preclinical trials with teriparatide led to a black box warning for the drug.

CONCLUSIONS: Teriparatide substantially increases spine and hip BMD and may offer additional benefits to patients with severe osteoporosis. Clinical trials comparing teriparatide with other available agents to treat osteoporosis are needed to more clearly define its place in therapy. Long-term safety and efficacy are not known.

Key Words: hPTH (1-34), osteoporosis, parathyroid hormone, teriparatide

Published Online, December 30, 2003. www.theannals.com, DOI 10.1345/aph.1D353

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-04-007-H01

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