Merck launches NORA study to examine risk of osteoporosis

Bone densitometry firms will probably benefit

A massive study designed to develop a database to identify women at risk of osteoporosis was launched this month with the backing of pharmaceutical giant Merck of Whitehouse Station, NJ, which markets the osteoporosis drug Fosamax. The National Osteoporosis Risk Assessment (NORA) program intends to build a database of 500,000 women in the U.S. within the next two years. This could eventually lead to increased use of bone densitometry as osteoporosis checkups become more routine.

NORA was debuted Oct. 18 at the Health Congress on Osteoporosis in Paris, France. The program is designed to gather data on osteoporosis risk factors and awareness of the disease that may help increase the historically low rate of bone-mass measurement testing in the U.S. Only 20% of primary-care physicians have ever prescribed a bone-mass measurement test, while osteoporosis goes undiagnosed in 80% of the 22 million women in the U.S. who are believed to have the disease.

NORA researchers plan to recruit women in 33 states over the next 18 months, eventually examining 500,000 patients. Women identified by their physicians to participate in the NORA study will receive a free osteoporosis risk factor assessment, including bone-mass measurement, risk factor questionnaires, and educational materials. The test results will be presented to the physicians, who will then determine the appropriate treatment strategies. The results will also be compiled in the database, which will provide physicians with data on the risk factors for the disease and the outcome of treatment. NORA is being administered by Paraxel International, a contract research organization.

Assuming its results support increased use of bone-mass testing, NORA will be a boon to the bone densitometry industry over the long run. It will also have short-term benefits, however, as bone densitometry equipment is diffused among the physicians participating in the study.

Merck plans to support the placement of bone densitometry systems through a leasing program handled by a third-party leasing company. The systems to be included in the NORA program will be selected by the program's steering committee, with an emphasis on the commercial availability and portability of the devices, according to a Merck spokesperson.

One bone densitometry vendor, Norland Medical Systems of White Plains, NY, has already been selected to have its products included in NORA. Norland's pDEXA and OsteoAnalyzer products are the first to be used by physicians in the program, and NORA's steering committee is examining bone densitometry systems manufactured by three other firms as well, according to the spokesperson.

NORA should be a shot in the arm to a market that has been flagging of late. The major densitometry vendors have reported disappointing financial results recently due to confusion over proposed reimbursement rates for densitometry studies to be set by the Health Care Financing Administration, which administers the federal government's Medicare program (see story, page 1).