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Title: Long-term Actonel Treatment Normalizes Bone Mineralization: Presented at ASBMR

"Long-term Actonel Treatment Normalizes Bone Mineralization: Presented at ASBMR"

By Bonnie Darves SEATTLE, WA -- October 5, 2004 -- Long-term treatment with oral risedronate sodium (Actonel) may help maintain bone mineralization at premenopausal levels in women with osteoporosis, according to results of a study presented here October 4[^th at the American Society for Bone and Mineral Research Annual Meeting.

The study, presented by Russell Turner, PhD, Professor of Orthopaedics, Mayo Clinic College of Medicine, found that after 3 years of treatment, bone mineralization levels returned to premenopausal levels.

The findings are important, he said, because there is an optimal range of bone mineralization, and it has been difficult to find treatments that effect a level of mineralization somewhere between "soft" bones and brittle bones, which are more prone to fracture. "The ideal is a state similar to that [found in] bones of healthy premenopausal women. This study shows that Actonel can increase mineralization to [those] levels," Dr. Turner said.

The small study enrolled 7 postmenopausal women with documented osteoporosis and taking 5 mg daily of Actonel, and 7 healthy premenopausal women whose mean age was 36 years. Periodic iliac crest biopsies were taken at baseline, 3 years and 5 years, and were measured by highly sensitive 3-dimensional microcomputed tomography to detect small changes in mineralization.

The 3-year findings, which the researchers reported previously, showed that 5 mg daily oral risedronate increased mean mineralization by 5.1% (P <.05). After 5 years of continuous treatment with risedronate 5 mg daily, mean mineralization was significantly higher compared to baseline (P <.05), but was maintained at the 3 year level, and was comparable to that of young premenopausal healthy women.

The ratio of lower to higher mineralized bone, which was reduced to 9% in the risedronate group after 3 years, was reduced to 16% after 5 years of treatment; this reduction is consistent with the reduction seen in bone turnover markers, Dr. Turner said, and was comparable to the ratio observed for the young healthy group (about 12%).

[Presentation title: "Five Year Risedronate Therapy Normalizes Mineralization: Synchrotron Radiation Micro-Computed Tomography Study of Sequential Triple Biopsies." Abstract SU436]

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