Magazine article Drug Topics

Calcitonin Nasal Spray: New Option for Osteoporosis

Magazine article Drug Topics

Calcitonin Nasal Spray: New Option for Osteoporosis

Article excerpt

The war against osteoporosis is continuing to escalate. With the Food & Drug Administration's approval of calcitonin-salmon nasal spray (Miacalcin) for the treatment of osteoporosis in postmenopausal women, Sandoz Pharmaceuticals Corp., East Hanover, N.J., has added another weapon to the arsenal.

Additional ammunition is also about to arrive with Merck & Co.'s osteoporosis drug alendronate (Fosamax). The drug is already approvable, and it is expected to be cleared before the end of the year.

Osteoporosis affects more than 25 million Americans--80% of them women. Osteoporosis is responsible for 1.5 million fractures each year. Of this number, 250,000 are hip fractures.

Hip fractures are the most common single cause of accidental death in women over the age of 75. Within one year of suffering a hip fracture, 20% of patients die; other patients with fractures trade their independence for nursing home care.

With a yearly cost in excess of $10 billion, osteoporosis is recognized as a major health problem.

Until recently, estrogen and injectable calcitonin were the only drugs approved to treat osteoporosis. Calcitonin injection on alternating days was not well received by all patients; nasal-spray calcitonin is expected to be more "patient friendly."

"The nice thing about osteoporosis medications is that we can tell when the drug is working," Michael Maricic, M.D., reported. "We can get a baseline bone density scan and repeat the scan after a certain length of time to make sure the drug is working."

Miacalcin's package insert reports that significant increases in bone mass density occur as early as six months after initiation of nasal-spray calcitonin therapy. Bone mass density increases persisted for up to two years of observation.

Clinical studies of calcitonin-salmon nasal spray in 551 "established" postmenopausal women showed a statistically significant increase in spinal bone density of 2%-3%, compared with those treated with placebo.

"The problem in postmenopausal osteoporosis," Maricic told Drug Topics, "is usually an accelerated turnover or breakdown of bone, that is, accelerated osteoclast activity. [With calcitonin spray] you have a natural hormone, and its main activity is to decrease the activity of the osteoclasts. It's a very nice physiologic fit for the disease." Maricic, an investigator involved in the clinical trials for calcitonin spray, is the clinical associate professor of rheumatology and associate section chief at the University of Arizona.

"Clinical significance [of osteoporosis treatment] really rests on fracture prevention," Said Maricic. …

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