Bone Fracture Rates Significantly Reduced Over Just Two Years in Patients Who Consistently Stayed on Bisphosphonate Therapy for Osteoporosis

Several Hundred Thousand Fractures Could Be Prevented Annually If Women Stayed on Therapy
WASHINGTON, DC -- 04/07/2005 -- Postmenopausal women with osteoporosis who consistently stayed on their bisphosphonate treatment were significantly less likely to experience a bone fracture over a two-year period than women who did not do so, according to findings(1) presented today at the Sixth International Symposium on Osteoporosis. The database analysis examined the relationship between adherence with newly prescribed bisphosphonate therapy -- the most commonly prescribed treatment for osteoporosis(2) -- and bone fracture risk in women with postmenopausal osteoporosis.

“We found that women with postmenopausal osteoporosis who faithfully continued to take their prescribed bisphosphonate medication reduced their risk for fractures substantially more -- about 25 percent -- than women who did not,” said Ethel Siris, M.D., professor of Clinical Medicine, Columbia University’s College of Physicians and Surgeons, and director, Toni Stabile Osteoporosis Center, New York-Presbyterian Hospital, New York, who presented the data at the meeting. “If this analysis is applied to the U.S. population, several hundred thousand bone fractures in postmenopausal women could potentially be prevented each year if women stayed on their bisphosphonate therapy,” she said.

Osteoporosis therapies must be taken long term to be effective. Patients may not stay on therapy, in part, because they see no obvious evidence of the disease or need for treatment unless they experience a bone fracture. A recent report by the U.S. Surgeon General recognizes adherence is poor with osteoporosis therapies, and suggests numerous strategies for improvement, including simplifying and organizing treatment regimens.(3)

Findings

The relationship between adherence to bisphosphonate therapy and fracture risk was examined over two years in 6,825 women, age 45 or older, diagnosed with postmenopausal osteoporosis. Adherence (how well the women consistently stayed on bisphosphonate treatment) was measured by refill compliance (drug available 80 percent or more of the time) and persistence (remaining on a bisphosphonate with no gaps in prescription refills greater than 30 days).

Only 21 percent of the women were persistent and 48 percent were refill compliant in the study. The relative risk of fracture was 26 percent lower among compliant vs. noncompliant patients, and 21 percent lower in persistent vs. nonpersistent patients.

The results are from a retrospective analysis of medical and pharmaceutical claims from the geographically diverse Medstat MarketScan® Research Database covering approximately six million individuals. The analysis was sponsored by Roche and GlaxoSmithKline.

About Osteoporosis

Osteoporosis, a disease in which bones become brittle and more likely to break, is considered so significant and such a prevalent public health issue that the U.S. Surgeon General issued the first-ever report on bone health and osteoporosis in October 2004, putting it on par with smoking and obesity as a major public health threat.(3) In the U.S. today, it is estimated that ten million individuals -- eight million of them women -- already have this debilitating disease. Another nearly 34 million have low bone mass (osteopenia), a condition that puts them at increased risk of developing osteoporosis. Further, the prevalence of osteoporosis is growing, due to an aging population.(4)

About Roche

Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. For further information, visit www.rocheusa.com.

About GSK

GSK, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GSK on the World Wide Web at www.gsk.com.

References

1. Siris E, Rosen CJ, Harris ST, Abbott TA, Barr CE, Silverman S. Adherence to bisphosphonate therapy: relationship to bone fractures at 24 months in women with postmenopausal osteoporosis. Abstract 397, oral and poster presentation at: Sixth International Symposium on Osteoporosis, National Osteoporosis Foundation, April 7, 2005, Washington, DC.

2. Stafford RS, Drieling RL, Hersh AL. National trends in osteoporosis visits and osteoporosis treatment, 1988-2003. Arch Intern Med Jul 26 2004;164(14):1525-1530.

3. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General; 2004.

4. America’s Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation. The National Osteoporosis Foundation; February 2002.

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