Sparse Data Exist for Alternative, Efficacious Therapies for Osteoporosis

SAN FRANCISCO — When it comes to alternative therapies for osteoporosis, data are sparse and most do not point to efficacy.

Speaking at the annual meeting of the International Society for Clinical Densitometry, Rogene Tesar, Ph.D., reported available data based on her review:

▸ Strontium. The form that is studied most of 20 supplement compounds is strontium ranelate, which consists of about 340 mg strontium in 1 g of compound.

The Food and Drug Administration is considering approval of strontium ranelate for the treatment of osteoporosis because in two large phase III studies it promoted bone formation, decreased resorption, and reduced fracture risk in postmenopausal women, said Dr. Tesar, who is in private practice in Austin, Texas. The Spinal Osteoporosis Therapeutic Intervention (SOTI) trial of 1,649 patients with a previous vertebral fracture found a 41% reduction in vertebral fracture risk after 3 years of taking strontium ranelate 2 g/day, compared with placebo. Bone mineral density (BMD) increased in the spine by 14% and in the hip by 8% in the strontium group, compared with placebo. The Treatment of Peripheral Osteoporosis (TROPOS) study of 5,091 patients with low hip BMD showed a 39% reduction in vertebral fractures and a 16% reduction in non-vertebral fractures, compared with placebo, over a 3-year period.

A related product, OsteoValin, has strontium carbonate as its main ingredient and is licensed in Europe as a prescription drug to treat osteoporosis. OsteoValin is available in the U.S. over the counter for around $27 for 30 capsules, Dr. Tesar said. Efficacy data, however, are based on only six patients and no control group. In addition, the product is not regulated well enough to ensure its quality and safety.

▸ Soy isoflavones. Although there is solid evidence for prevention of bone loss in animals given soy isoflavones, human data are mixed, Dr. Tesar said.

A double-blind, randomized, placebo-controlled study of 203 women within a decade of menopause reported in 2005 that high-dose isoflavones (80 mg) produced a mild but significant preservation of hip BMD over 1 year. A separate randomized, placebo-controlled study found that 2 years of soy milk with isoflavones prevented spine bone loss in postmenopausal women. The study concluded that two glasses of soy milk containing 76 mg isoflavones per day prevent lumbar spine bone loss.

▸ Vitamin K2. Positive evidence comes mainly from Japan, where a vitamin K2 compound called menatetrenone is standard treatment for osteopenia, Dr. Tesar said. A 2-year study of 241 osteoporotic women reported in 2000 that those taking 45 mg/day of a menatetrenone product called Gla-kay, plus calcium lactate, lost 1% of lumbar spine BMD, compared with a 3% loss in patients taking calcium supplements alone. A separate 2-year study of 172 postmenopausal women found a slight (0.1%) increase in lumbar spine density with vitamin K2 and a more marked (5%) increase with vitamin K2 plus vitamin D3.

▸ Tai Chi. A 1-year study of 34 postmenopausal women in 2002 found generalized bone loss in the 17 women who did 3.5 hours/week of tai chi and in the 17 who did not exercise, but the tai chi group had a lower rate of bone loss. A separate randomized study of 132 menopausal, sedentary women in 2004 also showed a lower rate of bone loss in those who practiced tai chi for 45 minutes a day, 5 days a week, compared with sedentary controls.

There is evidence for prevention of bone loss in animals given soy isoflavones, but human data are mixed. DR. TESAR

SAN FRANCISCO — When it comes to alternative therapies for osteoporosis, data are sparse and most do not point to efficacy.

Speaking at the annual meeting of the International Society for Clinical Densitometry, Rogene Tesar, Ph.D., reported available data based on her review:

▸ Strontium. The form that is studied most of 20 supplement compounds is strontium ranelate, which consists of about 340 mg strontium in 1 g of compound.

The Food and Drug Administration is considering approval of strontium ranelate for the treatment of osteoporosis because in two large phase III studies it promoted bone formation, decreased resorption, and reduced fracture risk in postmenopausal women, said Dr. Tesar, who is in private practice in Austin, Texas. The Spinal Osteoporosis Therapeutic Intervention (SOTI) trial of 1,649 patients with a previous vertebral fracture found a 41% reduction in vertebral fracture risk after 3 years of taking strontium ranelate 2 g/day, compared with placebo. Bone mineral density (BMD) increased in the spine by 14% and in the hip by 8% in the strontium group, compared with placebo. The Treatment of Peripheral Osteoporosis (TROPOS) study of 5,091 patients with low hip BMD showed a 39% reduction in vertebral fractures and a 16% reduction in non-vertebral fractures, compared with placebo, over a 3-year period.

A related product, OsteoValin, has strontium carbonate as its main ingredient and is licensed in Europe as a prescription drug to treat osteoporosis. OsteoValin is available in the U.S. over the counter for around $27 for 30 capsules, Dr. Tesar said. Efficacy data, however, are based on only six patients and no control group. In addition, the product is not regulated well enough to ensure its quality and safety.

▸ Soy isoflavones. Although there is solid evidence for prevention of bone loss in animals given soy isoflavones, human data are mixed, Dr. Tesar said.

A double-blind, randomized, placebo-controlled study of 203 women within a decade of menopause reported in 2005 that high-dose isoflavones (80 mg) produced a mild but significant preservation of hip BMD over 1 year. A separate randomized, placebo-controlled study found that 2 years of soy milk with isoflavones prevented spine bone loss in postmenopausal women. The study concluded that two glasses of soy milk containing 76 mg isoflavones per day prevent lumbar spine bone loss.

▸ Vitamin K2. Positive evidence comes mainly from Japan, where a vitamin K2 compound called menatetrenone is standard treatment for osteopenia, Dr. Tesar said. A 2-year study of 241 osteoporotic women reported in 2000 that those taking 45 mg/day of a menatetrenone product called Gla-kay, plus calcium lactate, lost 1% of lumbar spine BMD, compared with a 3% loss in patients taking calcium supplements alone. A separate 2-year study of 172 postmenopausal women found a slight (0.1%) increase in lumbar spine density with vitamin K2 and a more marked (5%) increase with vitamin K2 plus vitamin D3.

▸ Tai Chi. A 1-year study of 34 postmenopausal women in 2002 found generalized bone loss in the 17 women who did 3.5 hours/week of tai chi and in the 17 who did not exercise, but the tai chi group had a lower rate of bone loss. A separate randomized study of 132 menopausal, sedentary women in 2004 also showed a lower rate of bone loss in those who practiced tai chi for 45 minutes a day, 5 days a week, compared with sedentary controls.

There is evidence for prevention of bone loss in animals given soy isoflavones, but human data are mixed. DR. TESAR

SAN FRANCISCO — When it comes to alternative therapies for osteoporosis, data are sparse and most do not point to efficacy.

Speaking at the annual meeting of the International Society for Clinical Densitometry, Rogene Tesar, Ph.D., reported available data based on her review:

▸ Strontium. The form that is studied most of 20 supplement compounds is strontium ranelate, which consists of about 340 mg strontium in 1 g of compound.

The Food and Drug Administration is considering approval of strontium ranelate for the treatment of osteoporosis because in two large phase III studies it promoted bone formation, decreased resorption, and reduced fracture risk in postmenopausal women, said Dr. Tesar, who is in private practice in Austin, Texas. The Spinal Osteoporosis Therapeutic Intervention (SOTI) trial of 1,649 patients with a previous vertebral fracture found a 41% reduction in vertebral fracture risk after 3 years of taking strontium ranelate 2 g/day, compared with placebo. Bone mineral density (BMD) increased in the spine by 14% and in the hip by 8% in the strontium group, compared with placebo. The Treatment of Peripheral Osteoporosis (TROPOS) study of 5,091 patients with low hip BMD showed a 39% reduction in vertebral fractures and a 16% reduction in non-vertebral fractures, compared with placebo, over a 3-year period.

A related product, OsteoValin, has strontium carbonate as its main ingredient and is licensed in Europe as a prescription drug to treat osteoporosis. OsteoValin is available in the U.S. over the counter for around $27 for 30 capsules, Dr. Tesar said. Efficacy data, however, are based on only six patients and no control group. In addition, the product is not regulated well enough to ensure its quality and safety.

▸ Soy isoflavones. Although there is solid evidence for prevention of bone loss in animals given soy isoflavones, human data are mixed, Dr. Tesar said.

A double-blind, randomized, placebo-controlled study of 203 women within a decade of menopause reported in 2005 that high-dose isoflavones (80 mg) produced a mild but significant preservation of hip BMD over 1 year. A separate randomized, placebo-controlled study found that 2 years of soy milk with isoflavones prevented spine bone loss in postmenopausal women. The study concluded that two glasses of soy milk containing 76 mg isoflavones per day prevent lumbar spine bone loss.

▸ Vitamin K2. Positive evidence comes mainly from Japan, where a vitamin K2 compound called menatetrenone is standard treatment for osteopenia, Dr. Tesar said. A 2-year study of 241 osteoporotic women reported in 2000 that those taking 45 mg/day of a menatetrenone product called Gla-kay, plus calcium lactate, lost 1% of lumbar spine BMD, compared with a 3% loss in patients taking calcium supplements alone. A separate 2-year study of 172 postmenopausal women found a slight (0.1%) increase in lumbar spine density with vitamin K2 and a more marked (5%) increase with vitamin K2 plus vitamin D3.

▸ Tai Chi. A 1-year study of 34 postmenopausal women in 2002 found generalized bone loss in the 17 women who did 3.5 hours/week of tai chi and in the 17 who did not exercise, but the tai chi group had a lower rate of bone loss. A separate randomized study of 132 menopausal, sedentary women in 2004 also showed a lower rate of bone loss in those who practiced tai chi for 45 minutes a day, 5 days a week, compared with sedentary controls.

There is evidence for prevention of bone loss in animals given soy isoflavones, but human data are mixed. DR. TESAR