Forteo For Osteoporosis. Is This The Right Treatment For You?
Forteo for osteoporosis treatment may be prescribed for severe cases... but usually only as a temporary measure.
A Forteo injection program is sometimes prescribed to treat severe osteoporosis in postmenopausal women and in men... usually when other treatments have failed. It is also used to treat poor bone density associated with long-term use of corticosteroid medications. The drug was approved by the US FDA in 2001 and in Canada in July, 2008.
Forteo is a human-made recombinant parathyroid hormone that works to increase bone formation by stimulating osteoblast cells into overactivity. This distinguishes it from drugs such as Fosamax, Actonel and Boniva that work to halt bone breakdown.
RESEARCH CONDUCTED ON HUMANS LASTED LESS THAN TWO YEARS
Short-term research conducted on 1637 postmenopausal women with severe osteoporosis found that Forteo increased bone density by an average 9.7% in the spine and 2.6% in the total hip... while the wrist lost bone density and total body mineral content remained the same.
While these results are attractive, the shortness of the research is of great concern. The manufacturer specifically states, “The safety and efficacy of Forteo have not been evaluated beyond two years (median 19 months in women and 10 months in men). Consequently, the maximum lifetime exposure to Forteo for an individual patient is 18 months.”
Also of concern are the results of earlier animal safety studies in which Forteo was shown to cause a high incidence of osteosarcoma (a rare malignant, often fatal, bone tumor), osteoblastoma (abnormal mass of tissue in bone) and osteoma (small benign bone lesions). As with all drug safety tests, the drug doses tested were 3x, 20x and sometimes 60x higher than those used in human medications. Notably, bone tumors were observed at all Forteo doses, with the incidence reaching 40–50% in the higher-dose groups. Given this safety concern, guidelines were set to limit the duration of its use in humans and the FDA has required a “black box” label warning stating the increased cancer risk shown in rat studies.
FORTEO USE IS SHORT-TERM
Forteo for osteoporosis treatment is generally prescribed only under severe circumstances when other osteoporosis treatments have failed. The drug is expensive ($600–$700 per month) and inconvenient to use as it requires a daily self-administered injection.
Although there may be significant bone density gains while using Forteo for osteoporosis, the research also shows that gains are lost once the drug is stopped. To maintain bone density gains, antiresorptive drugs such as Fosamax or Evista must be used after stopping the use of Forteo.