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Position Statement on Teriparatide (Forteo)

The mechanism of action of teriparatide is anabolic, and unique among agents approved for treatment of bone loss, acting directly on osteoblasts to promote bone formation. The rate and amount of bone mineral density increase are significantly higher than those seen with bisphosphonate therapy, making this agent particularly useful for patients with the most advanced bone loss and the highest risk of subsequent fracture. Teriparatide is therefore unique among currently available therapies in its ability to rapidly alter the clinical course of osteoporosis. It may also be the preferable therapy for patients who are intolerant of or unresponsive to bisphosphonate therapy.

Patient selection for treatment should be based on DEXA t-scores (using WHO criteria for the diagnosis of osteoporosis) as well as clinical risk factors. Teriparatide should be considered for patients determined by the treating physician to have severe osteoporosis. Some patients with osteopenia by t-score may have atraumatic fractures and therefore may also be candidates for therapy.

Based on current information, therapy should be administered for a maximum of two years.

This medical option should be available without prior authorization to Rheumatologists and Endocrinologists trained in evaluation and treatment of patients with metabolic bone disease. The presence of severe osteoporosis by DEXA and/or evidence of fragility fractures should be requisite for approval of this agent for other physicians.

Neer, RM, et al. N Engl J Med. 2001:344(19): 1434-1441

February 24, 2003

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