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EMBARGOED FOR RELEASE UNTIL 12:30 P.M. (CDT) ON SEPTEMBER 23, 2005

STUDY CONFIRMS STRONTIUM RANELATE’S UNIQUE, DUAL MODE OF ACTION IN TREATING OSTEOPOROSIS

Nashville (Sept. 23, 2005) – New data presented at the 27th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) provide direct cellular evidence that strontium ranelate (SR), a new osteoporosis medication, decreases bone resorption while increasing bone formation. Strontium ranelate (Protelos, manufacturer: Servier) is the only available osteoporosis treatment [in Europe only] that exhibits a dual mode of beneficial action on bone formation and resorption.

Bone remodeling is the lifelong process by which new bone is formed and old bone is broken down, or resorbed. In children, teens and young adults, more bone is formed than resorbed. In healthy adults the amount of bone formed equals the amount resorbed. With aging, however, there is increasing bone breakdown and the ability to replace the resorbed bone with newly formed bone decreases. This results in a gradual decline in the amount of bone, and an increase in bone fragility, leading to osteoporosis which can lead to broken bones or fractures.

The majority of medications used to treat osteoporosis, such as bisphosphonates, prevent bone destruction by reducing bone resorption. However, since the processes of resorption and formation are linked, such drugs also decrease bone formation. On the other hand, treatments that build new bone, such as parathyroid hormone (PTH), do so by increasing the amount of bone formation. However, PTH also increases bone resorption.

Pierre D. Delmas, M.D., principal study author Monique E. Arlot, M.D., and their colleagues at Université Claude Bernard of Lyon, France, compared hip bone biopsy specimens taken from 49 postmenopausal women with osteoporosis treated with strontium ranelate and 87 postmenopausal women given placebo. Biopsies were taken either at the beginning of the study or after one, two, three, four or five years of treatment. In the SR-treated group, researchers found statistically significant evidence of increased activity of bone-building cells, called osteoblasts, and a tendency toward decreased activity of the cells that break down and remove bone, called osteoclasts.

Large clinical trials have shown that 2g. per day of oral SR reduced spine fracture risk in postmenopausal osteoporotic women by 41 percent over three years, and reduced hip fracture risk in osteoporotic women aged 74 years and older by 36 percent over three years. These studies have shown SR to be well tolerated with no major side effects. Although available in Europe, SR has not been approved by the U.S. Food and Drug Administration.

ASBMR President-Elect Elizabeth Shane, M.D., notes: “The data presented in this abstract are highly significant because they represent the first direct biopsy evidence that the tightly linked processes of bone formation and resorption can be dissociated in a manner that can benefit the skeleton by lowering the risk of fracture. Strontium should prove to be a useful addition to the group of drugs used to treat osteoporosis.”

Disclosures: The study discussed in this press release was funded by Servier. Dr. Arlot and Dr. Delmas have received consulting fees or other remuneration from Servier.

To obtain a copy of the scientific abstract, contact Ms. Melissa Haynes (contact information above).

The ASBMR Annual Meeting is the preeminent international scientific meeting on bone and mineral research. More than 5,300 medical professionals and scientists from around the world are expected to attend the September 23-27, 2005, meeting in Nashville, where more than 1,900 research abstracts will be presented. The ASBMR is the foremost professional, scientific and medical society for the promotion of bone and mineral research and the translation of that research into clinical practice. To learn more, visit the ASBMR website at www.asbmr.org.

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