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Two large studies released at IOF World Congress on Osteoporosis

May 17, 2004

Strontium ranelate can prevent both hip and vertebral fractures in women over 70 years old, researchers reported this week at the IOF World Congress on Osteoporosis in Rio de Janeiro (conference abstract OC 39).

Women in this age bracket have an elevated risk of sustaining hip fractures, which have been shown to increase mortality at the rate of 15 to 30 percent, mostly within the first six months after the fracture. Data show that two grams of strontium ranelate, taken daily, can reduce the risk of hip fractures in this subpopulation by 36%, and vertebral fractures by up to 59%.

The bone-saving properties of strontium ranelate were evaluated in two randomized, double-blind, placebo controlled trials. The five-year TROPOS (TReatment Of Peripheral OSteoporosis) study was designed to evaluate the efficacy of the drug in treating peripheral fractures, while the Spinal Osteoporosis Therapeutic Intervention (SOTI) study was designed to assess the drug's ability to reduce new vertebral fractures in women with low bone mineral density, commonly called osteopenia.

"This is an efficacious and rapidly acting drug in reducing fracture risk in postmenopausal women (working within a year of therapy), and it is well tolerated," said Prof. Rene Rizzoli, Division of Bone Diseases, University Hospital, Geneva, Switzerland, and chairman of IOF's Committee of Scientific Advisors. Rizzoli and colleagues analyzed data from a subset of almost 2,000 TROPOS volunteers-women who were over age 74 at the start of the study, and who had low bone mineral density in the neck of the femur, a commonly used test to identify those with osteoporosis. Around half of these patients (982) received the strontium ranelate formulation daily for three years, while the remainder (995) received a placebo. All volunteers also received daily calcium and vitamin D supplements. At the end of the three-year period those receiving the drug had a significant reduction (36%) in the relative risk of hip fracture.

"This is an exciting new drug for women," said Prof. Ego Seeman, Austin Hospital, University of Melbourne, Australia. Seeman, editor of IOF's publication Progress in Osteoporosis, and colleagues tested the vertebra-saving property of strontium ranelate using combined data from both the TROPOS and SOTI trials (conference abstract OC45). They focused on 1170 of the participants who had osteopenia of the lumbar spine at the start of the trial. Just over 700 of these patients had already sustained a fragility fracture before strontium ranelate treatment began. During the first three years of the trial, the remaining, or 448 volunteers, reduced their risk of vertebral fracture by 59%.

Significantly, Seeman found that those who had sustained fragility fractures also decreased their risk of vertebral fracture, by 37%, while taking strontium ranelate. "Most fractures in the community occur in women with moderate risk i.e. those with osteopenia," said Seeman, "but as yet no drugs have been shown to reduce fracture risk in these moderate risk women. These results are reassuring and solidify the overall findings that this new drug reduces the risk of spine fractures in women with osteoporosis and osteopenia."

Bone is a dynamic structure in which bone is created and destroyed through a person's life. New bone is constantly being laid down by bone cells called osteoblasts, in a process called apposition, and removed by cells called osteoclasts, in a process called resorption. In young people, growing bones achieve peak bone mass in the teenage years and early 20s. As people age, bones begin to weaken and the balance shifts so that resorption gains the upper hand, resulting in low bone mineral density (osteopenia), or severe low bone mineral density (osteoporosis). People with osteoporosis are at increased risk for fracture, commonly of the hip or vertebrae.

Worldwide, hip fractures due to osteoporosis are expected to rise from 1.7 million annually to 6.3 million annually by 2050. Close to one out of two women over the age of 50 will experience an osteoporotic fracture in their lifetime, as will one of five men.

Strontium is a naturally occurring element which is well tolerated when complexed with ranelic acid. Unlike some existing therapies for osteoporosis, strontium ranelate actually promotes the net formation of bone by preferentially activating osteoblasts.


The International Osteoporosis Foundation (IOF) is a worldwide organization dedicated to the fight against osteoporosis. It brings together scientists, physicians, patient societies and corporate partners. Working with its 165 member societies in more than 85 locations, and other healthcare-related organizations around the world, IOF encourages awareness and prevention, early detection and improved treatment of osteoporosis.

Osteoporosis, in which the bones become porous and break easily, is one of the world's most common and debilitating diseases. The result: pain, loss of movement, inability to perform daily chores, and in many cases, death. One out of three women over 50 will experience osteoporotic fractures, as will one out of eight men(1). Unfortunately, screening for people at risk is far from being a standard practice. Osteoporosis can, to a certain extent, be prevented, it can be easily diagnosed and effective treatments are available.

1 Melton U, Chrischilles EA, Cooper C et al. How many women have osteoporosis? Journal of Bone Mineral Research, 1992; 7:1005-10

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