HONOLULU, Sept. 17 /PRNewswire-FirstCall/ -- In a new analysis reported at the American Society for Bone and Mineral Research (ASBMR) 29th Annual Meeting, risedronate 5 mg decreased clinical fracture risk by 50% over three years relative to placebo in a group of postmenopausal women with osteoporosis who had suffered a previous hip fracture. This retrospective analysis of the risedronate HIP trial(1) evaluated the combined incidence of vertebral and nonvertebral clinical fractures among this high risk group of patients.
“As physicians we want assurance that a therapy is effective at treating varying severities of disease,” said Michael McClung, M.D., Founding Director of the Oregon Osteoporosis Center in Portland and a primary investigator of the study. “In this analysis risedronate effectively reduced fracture risk among patients with severe osteoporosis.”
According to the National Osteoporosis Foundation, a history of prior fracture is an important risk factor for future fracture. After a postmenopausal woman suffers a hip fracture, her risk approximately doubles for sustaining another fracture.
“These at-risk patients need to be identified and considered for therapy that can help prevent another fracture from occurring,” said Dr. McClung.
About the Analysis
In the HIP trial(1), there were 339 postmenopausal women between ages 70-79 years with low bone mineral density (BMD) and a history of at least one hip fracture prior to the study. These patients were treated with either placebo (PLC) or risedronate (RIS) 2.5 mg or 5 mg daily. Over the 3 year period, the clinical fracture incidences were 28.4%, 14.9% and 13% for the PLC, RIS 2.5 mg and RIS 5 mg groups, respectively. This corresponds to a 50% reduction in clinical fracture risk relative to placebo for both the 2.5 mg and 5 mg treatment groups (p=0.031 and p=0.048, respectively).
The incidence of osteoporosis-related clinical fracture, defined by the occurrence of radiographically confirmed clinical vertebral fracture or radiographically confirmed non-traumatic non-vertebral fracture was calculated using Kaplan-Meier survival estimates over a 3 year period and was compared between placebo- and risedronate-treated patients. Treatments were compared using log rank test, and the risk ratio and its 95% confidence interval were obtained using a Cox regression model stratified for study. Subjects’ mean age was 75 years, and their mean femoral neck (FN) and lumbar spine (LS) T-scores were -3.1 and -3.2 SD, respectively. Baseline characteristics were well balanced between the 3 treatment groups.
This study was sponsored by The Alliance for Better Bone Health.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. It is a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.
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About sanofi-aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris and in New York .
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(1) McClung MR, Geusens P, Miller PD, et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344:333-340
The Alliance for Better Bone Health
CONTACT: Paula Koenigs of Procter & Gamble Pharmaceuticals,+1-513-622-3923, on-site, +1-513-293-9724, koenigs.pm@pg.com; Terri Pedoneof sanofi-aventis U.S., +1-908-981-6562, terri.pedone@sanofi-aventis.com;or Angela Collom of Dorland Global Public Relations, +1-215-928-2188,acollom@dorland.com, for The Alliance for Better Bone Health
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