Bone Growth Drug Forteo Gets FDA OK
Dr. David J. Demko, Gerontologist
AgeVenture News Service (12-02-02)
Old bones can be as fragile as china, and who knows that
better than China where osteoporosis has reached epidemic proportion, 300% increase in the last 30 years. Blame it on lifestyle, not aging. Diets high in animal protein, high in salt and low in calcium are detrimental to bones, say Hong Kong researchers. Dietary calcium intake for Hong Kong residents is 400mg per day, less than 50% of that in Caucasians. Moreover, in those elders whose dietary calcium intake is lowest, twenty-five percent, the rate of fractured hip and spine was 200% higher than normal. Bottom-line ... bad diet, bad bones. But don't stop there. Prevention requires more than dietary discipline. The sedentary life-style of Hong Kong Chinese, 95% do not exercise regularly, is what best accounts for the recent epidemic of osteoporosis, say Hong Kong researchers. Here in the United States, hip fractures are associated with a 30% increase in mortality, underscoring the importance of building and maintaining bone mass. Makes you wonder if anyone has any new ideas for treating osteoporosis? The answer is "Yes". Just now. Read on.
One out of every two women and
one in eight men over age 50 will have an osteoporosis-related fracture in the span of a lifetime. Osteoporosis is a progressive thinning of bones that may lead to an increased risk of spine, wrist, and hip fractures. Osteoporosis is responsible for more than 1.5 million fractures annually, including
300,000 hip fractures,
700,000 spinal fractures,
250,000 wrist fractures, and
300,000 miscellaneous fractures.
Thank goodness, help is on the way. The U.S. Food and Drug Administration (FDA) has approved a new bone-building drug called "teriparatide". The new treatment is directed at osteoporosis in postmenopausal women who are at high risk for having a fracture. The drug is also approved to increase bone mass in men who are at high risk for fracture.
Teriparatide is the first approved agent for the treatment of osteoporosis that stimulates new bone formation.
The new drug is administered by injection once a day in the thigh or abdomen in recommended dosages of 20 mcg per day. Daily injections of teriparatide stimulate new bone formation leading to increased bone mineral density. Drugs approved to treat osteoporosis, say FDA researchers, must be shown to preserve or increase bone density and maintain bone quality.
Patients treated with 20 mcg of teriparatide per day, along with calcium and vitamin D supplementation, had statistically significant increases in bone mineral density (BMD) at the spine and hip. Clinical trials also demonstrated that teriparatide reduced the risk of vertebral and non-vertebral fractures in postmenopausal women. The effects of teriparatide on fracture risk have not been studied in men.
In animal studies with teriparatide, there was an increase in the number of rats developing osteosarcoma, a
rare but serious cancer of the bone. In the human studies,no osteosarcomas were reported, but the possibility
that humans treated with teriparatide may face an increased risk of developing this cancer cannot be ruled out,
a concern that will be addressed in a brochure, called a Medication Guide for patients. In addition, side effects associated with teriparatide included nausea, dizziness, and leg cramps.
FDA cautions that persons with hypercalcemia, women who are pregnant or nursing, or persons who have ever been diagnosed with bone cancer or other cancers that have spread to the bones, should not use teriparatide.
Since the effects of long-term treatment are not yet known, users are advised not to continue therapy beyond 24 months. Teriparatide is manufactured by Eli Lilly and Company of Indianapolis, and will be marketed under the trade name "Forteo".
See related articles in AgeVenture archives.
Bone-Builder Drug Better Than Estrogen
High Protein Diet High Risk for Elder Bones
Osteoporosis Is Preventable Says Chinese Medical Team
AgeVenture News Service, www.demko.com
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