A new drug called Forteo (generic name, teriparatide) may soon be the first FDA approved drug that actually helps form new bone in patients with osteoporosis, a degenerative bone disease. In a newly published study, Forteo significantly reduced the incidence of spinal and non-spinal fractures and increased bone mineral density in post-menopausal women with osteoporosis. Forteo is identical to a portion of the human parathyroid protein, a hormone responsible for bone formation. Eli Lilly, the maker of Forteo, expects FDA approval by the end of 2001.
"This research is very exciting for the future treatment of osteoporosis," said Conrad Johnston, Jr., MD, President of the National Osteoporosis Foundation (NOF), in an NOF news release. "If parathyroid hormone treatment [Forteo] receives approval for osteoporosis from the Food and Drug Administration (FDA), it would be the first treatment option to build substantial amounts of bone by increasing bone formation," said Dr. Johnston.
In the study, lead researcher Dr. Robert Neer of the Osteoporosis Center at Massachusetts General Hospital and his colleagues enrolled 1,637 post-menopausal women with osteoporosis-related fractures. Each of the women was randomly assigned to receive either 20 micrograms (m g) or 40 m g of Forteo or to receive a placebo (an inactive substance). All of the patients also received daily calcium and vitamin D supplements.
After an average follow-up of 18 months, Dr. Neer and his colleagues found that women who received Forteo were nearly 90% less likely to experience severe or moderate spinal fractures when compared to those who received a placebo. Women who received Forteo were also less likely to experience non-spinal fractures at sites such as the wrist, hip, ankle/foot, ribs, etc. than women who did not receive Forteo. Additionally, women who received Forteo experienced increases in bone mineral density as early as three months after beginning treatment.
Study Results with Forteo Versus No Treatment |
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| Received 20 m g of Forteo |
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| Received 40 m g of Forteo |
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Side effects of Forteo were mild to moderate in the study. Dizziness and legs cramps were the most common side effects in women who received 20 m g of Forteo. At the 40 m g dose, some women also experienced headache and nausea. One drawback to Forteo is that it must be injected by the patient or a healthcare provider, making it less convenient than an oral medication. However, the researchers said that the patients in the study quickly learned how to self-inject Forteo.
FDA approval of Forteo is expected to come in late 2001. Development of Forteo was suspended in 1998 after rats who were given lifelong doses of Forteo developed bone cancer. However, extensive analysis by oncologists and researchers revealed no threat of cancer in humans.
Osteoporosis is a degenerative bone disease that affects primarily post-menopausal women. The disease is a threat to 28 million Americans and is currently one of the most under-diagnosed and under-treated disorders in medicine. It is estimated that one in two women over 50 will have an osteoporosis-related fracture. Click here or choose from the links below to learn more about osteoporosis.
- The May 9, 2001 Eli Lilly and Company news release, "New England Journal of Medicine Reports Lilly’s Investigational Bone Formation Drug Demonstrated Significant Fracture Risk Reduction in Post-Menopausal Women with Osteoporosis-Related Fractures," is available at http://newsroom.lilly.com/news/story.cfm?id=791
- The study, "Effects of Parathyroid Hormone (1-34) on Fractures and Bone Mineral Density in Post-Menopausal Women," is published in the May 10, 2001 issue of the New England Journal of Medicine. An abstract of the study is available at http://www.nejm.org/content/2001/0344/0019/1434.asp
- The May 9, 2001 National Osteoporosis Foundation news release, "Statement from the National Osteoporosis Foundation on the Results of Experimental Bone-Building Treatment," is available at http://www.nof.org/news/pressreleases/nejm_pth.html
- To learn more about treating osteoporosis, please visit http://www.imaginis.com/osteoporosis/osteo_treatment.asp
- To learn more about preventing osteoporosis, please visit http://www.imaginis.com/osteoporosis/osteo_prevent.asp
