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TORONTO — The extension phases of two large trials evaluating strontium ranelate for the prevention of osteoporotic fractures have shown that the efficacy previously seen at 3 years holds up during years 4 and 5, Dr. Jean-Yves Reginster said at a world congress on osteoporosis.
Efficacy of strontium ranelate was confirmed for both vertebral and nonvertebral fractures, Dr. Reginster said.
After 4 years of treatment, patients in the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial randomized to receive strontium ranelate had a significant 33% reduction in risk of new vertebral fractures compared with on placebo, said Dr. Reginster of the University of Liège, Belgium. The trial included 1,649 women with postmenopausal osteoporosis whose mean age was 69 years and whose mean lumbar spine bone mineral density T score was −3.6. They were recruited from 72 centers in 11 European countries and Australia. All had had at least one vertebral fracture.
Study patients were randomized to receive 2 g of oral strontium ranelate daily or placebo, and initially were followed for 3 years, at which time treatment was associated with a 41% risk reduction for vertebral fractures (N. Engl. J. Med. 2004;350:459-68).
In the second trial, the Treatment of Peripheral Osteoporosis (TROPOS) study, treatment with 2 g/day strontium ranelate among 5,091 postmenopausal women with osteoporosis was associated with a 16% relative risk reduction for all nonvertebral fractures at 3 years and a 39% reduction for vertebral fractures (J. Clin. Endocrinol. Metab. 2005; 90:2816-22).
At 5 years, the relative risk reduction for nonvertebral fractures was 15%, and for vertebral fractures the risk reduction was 24%.
Patients in this study were older, averaging 76.7 years, Dr. Reginster said. Mean femoral neck T score was −3.1. With regard to safety, no new concerns arose. “Among all patients at the beginning of the trials there was a slight increase in the incidence of deep vein thrombosis, but this vanished over time and was no longer apparent during years 4 and 5,” he said at the meeting, sponsored by the International Osteoporosis Foundation.
After 4 years, patients taking strontium ranelate had a significant 33% reduction in risk. DR. REGINSTER
TORONTO — The extension phases of two large trials evaluating strontium ranelate for the prevention of osteoporotic fractures have shown that the efficacy previously seen at 3 years holds up during years 4 and 5, Dr. Jean-Yves Reginster said at a world congress on osteoporosis.
Efficacy of strontium ranelate was confirmed for both vertebral and nonvertebral fractures, Dr. Reginster said.
After 4 years of treatment, patients in the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial randomized to receive strontium ranelate had a significant 33% reduction in risk of new vertebral fractures compared with on placebo, said Dr. Reginster of the University of Liège, Belgium. The trial included 1,649 women with postmenopausal osteoporosis whose mean age was 69 years and whose mean lumbar spine bone mineral density T score was −3.6. They were recruited from 72 centers in 11 European countries and Australia. All had had at least one vertebral fracture.
Study patients were randomized to receive 2 g of oral strontium ranelate daily or placebo, and initially were followed for 3 years, at which time treatment was associated with a 41% risk reduction for vertebral fractures (N. Engl. J. Med. 2004;350:459-68).
In the second trial, the Treatment of Peripheral Osteoporosis (TROPOS) study, treatment with 2 g/day strontium ranelate among 5,091 postmenopausal women with osteoporosis was associated with a 16% relative risk reduction for all nonvertebral fractures at 3 years and a 39% reduction for vertebral fractures (J. Clin. Endocrinol. Metab. 2005; 90:2816-22).
At 5 years, the relative risk reduction for nonvertebral fractures was 15%, and for vertebral fractures the risk reduction was 24%.
Patients in this study were older, averaging 76.7 years, Dr. Reginster said. Mean femoral neck T score was −3.1. With regard to safety, no new concerns arose. “Among all patients at the beginning of the trials there was a slight increase in the incidence of deep vein thrombosis, but this vanished over time and was no longer apparent during years 4 and 5,” he said at the meeting, sponsored by the International Osteoporosis Foundation.
After 4 years, patients taking strontium ranelate had a significant 33% reduction in risk. DR. REGINSTER
TORONTO — The extension phases of two large trials evaluating strontium ranelate for the prevention of osteoporotic fractures have shown that the efficacy previously seen at 3 years holds up during years 4 and 5, Dr. Jean-Yves Reginster said at a world congress on osteoporosis.
Efficacy of strontium ranelate was confirmed for both vertebral and nonvertebral fractures, Dr. Reginster said.
After 4 years of treatment, patients in the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial randomized to receive strontium ranelate had a significant 33% reduction in risk of new vertebral fractures compared with on placebo, said Dr. Reginster of the University of Liège, Belgium. The trial included 1,649 women with postmenopausal osteoporosis whose mean age was 69 years and whose mean lumbar spine bone mineral density T score was −3.6. They were recruited from 72 centers in 11 European countries and Australia. All had had at least one vertebral fracture.
Study patients were randomized to receive 2 g of oral strontium ranelate daily or placebo, and initially were followed for 3 years, at which time treatment was associated with a 41% risk reduction for vertebral fractures (N. Engl. J. Med. 2004;350:459-68).
In the second trial, the Treatment of Peripheral Osteoporosis (TROPOS) study, treatment with 2 g/day strontium ranelate among 5,091 postmenopausal women with osteoporosis was associated with a 16% relative risk reduction for all nonvertebral fractures at 3 years and a 39% reduction for vertebral fractures (J. Clin. Endocrinol. Metab. 2005; 90:2816-22).
At 5 years, the relative risk reduction for nonvertebral fractures was 15%, and for vertebral fractures the risk reduction was 24%.
Patients in this study were older, averaging 76.7 years, Dr. Reginster said. Mean femoral neck T score was −3.1. With regard to safety, no new concerns arose. “Among all patients at the beginning of the trials there was a slight increase in the incidence of deep vein thrombosis, but this vanished over time and was no longer apparent during years 4 and 5,” he said at the meeting, sponsored by the International Osteoporosis Foundation.
After 4 years, patients taking strontium ranelate had a significant 33% reduction in risk. DR. REGINSTER