Forteo: Parathyroid Treatment for Osteoporosis


Forteo (teriparatide) is a new treatment for osteoporosis. It has been approved by the US Food and Drug Administration for post-menopausal women who have been diagnosed with osteoporosis, for men with primary or hypogonadal osteoporosis, as well as men and women with a history of osteoporosis-related fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy. It is administered via daily injections.

The drug is based on the parathyroid hormone and significantly increases the rate of bone formation. It increases the number and stimulates the action of bone forming cells called osteoblasts. Currently available osteoporosis medications such as the bisphosphonates Fosamax or Actonel are antiresorptives that work to slow or stop bone loss by reducing the number and limiting the action of bone-removing cells called osteoclasts.

A major safety concern for teriparatide became apparent during a two-year study in rats. Teriparatide seemed to cause an increase in the incidence of osteosarcoma, a malignant bone tumor, in the test animals. No cases of osteosarcoma have been reported during the human trials, but the possibility that humans treated with Forteo (teraparatide) are at increased risk for this cancer cannot be ruled out. The FDA recommends against treatment with teriparatide for children and adolescents because their growing bones put them at a higher risk for developing osteosarcoma. Because the effects of long-term use are not known at this time, therapy for more than 2 years is not recommended.

According to the statements from the FDA and Eli Lilly and Company (the drug's manufacturer), Forteo should not be taken by individuals with high levels of calcium in their blood, women who are pregnant or nursing, by those with a history of bone cancers or by those with metabolic bone diseases other than osteoporosis. OI would be included in this group.

At this time, there is no evidence, pro or con, concerning use of this drug for the treatment of osteogenesis imperfecta in adults or children. This drug is considered inappropriate for use with children. There is also no evidence regarding the use of this drug for the treatment of osteoporosis in adults who also have OI.

(Information in the above statement is based on statements on the FDA web site, www.FDA.gov and the Eli Lilly and Company web site www.lilly.com.  The OI Foundation will continue to monitor information about this new drug and will report new findings as they relate to osteogenesis imperfecta as they become available.)


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