Bone-Disease Victims Seek OK of New Drug
GAITHERSBURG, Md. (AP) _ Victims of osteoporosis asked the Food and Drug Administration on Thursday to approve the first new drug to treat the debilitating bone disease in 10 years.
″Please do whatever you can to makes sure effective drugs to fight this life-diminishing disease are made available to us who need it so desperately,″ said Aileen Knapp, 71, of Washington, who credits the drug with slowing her osteoporosis.
FDA advisers are considering whether etidronate, which would be the first non-hormonal treatment for osteoporosis, would help patients slow the rapid bone loss that occurs with the disease.
At a packed hearing, 10 people afflicted by osteoporosis and ranging in age from 36 to 79, begged the government to put these new therapies on a fast track to see if they truly work.
Osteoporosis causes the bones to gradually become so brittle that they break easily. It afflicts 25 million Americans, 80 percent of them women, and about 200 million people worldwide. The disease causes 1.5 million bone fractures a year and 50,000 deaths. Its risk increases with age.
Only two drugs in the United States are approved to fight it: estrogen, for post-menopausal women, and a thyroid-produced hormone called calcitonin that must be injected once a day. Hormones have frequent side effects and many women, in particular, can’t take estrogen if they are at high risk for breast cancer.
The proposed drug, sold by Procter & Gamble Co. under the name Didrocal, already is being used by many woman without FDA approval. But other doctors are reluctant to prescribe it without the agency’s backing and without knowing the optimal dose.
Procter & Gamble said Thursday that osteoporosis patients should take 400 milligrams of Didrocal a day for 14 days and then take calcium, vital for bone growth, for the next 76 days in a continuing cycle, presumably for the rest of their lives.
One study showed that women who followed this pattern for three years had twice the chance of remaining fracture-free over patients who only took calcium.
The studies found that didrocal would be as effective as estrogen in slowing bone loss but would be an alternative for people wary of hormones, said Dr. Douglas Alexrode of Procter & Gamble. And a colleague, Dr. Anne Geddes, said the drug was so safe that it would take 16 times the average dose for the bone to be damaged.
Didrocal works by forming a protective barrier on the most vulnerable layer of bone that protects it from body cells that actually destroy bone’s mineral content. This destruction is part of a life-and-death bone cycle that becomes unbalanced as people age to favor the destruction over the regrowth of bone mineral.
The only way to prevent osteoporosis is a lifetime of calcium consumption, particularly when people are in their teens and early 20s.
They are no drugs on the horizon to prevent osteoporosis, said Dr. Hunter Heath of the University of Utah. But other drugs are being studied to see if they, too, would help slow the disease. These include a metabolic product of vitamin D called calcitriol and several growth hormones.
″But I don’t think we’re going to see any miracles in the near future,″ Heath said.