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| LAST UPDATED : Jan 25th, 2003 - 22:05:05 |
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Osteoporosis
Teriparatide May Build Bone Best When Used Alone Mitchel L. Zoler Philadelphia Bureau SAN ANTONIO — The next new drug for building stronger bones, a recombinant fragment of human parathyroid hormone, seems to work best when used on its own, without concurrent treatment with a bisphosphonate or raloxifene, experts said at the annual meeting of the American Society for Bone and Mineral Research. Their conclusions were based in part on early results presented at the meeting from a pair of studies examining how treatment with human parathyroid hormone interacts with alendronate (Fosamax) or raloxifene (Evista). Teriparatide, the 1-34, N-terminal fragment of recombinant, human parathyroid hormone, is expected to reach the U.S. market in 2003 under the trade name Forteo. The Food and Drug Administration has approved the drug, made by Eli Lilly & Co., to treat osteoporosis in postmenopausal women at high risk of fracture and to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk. (See story on p. 7.) “Many patients continue to have osteoporosis despite treatment with an antiresorptive drug,” such as a bisphosphonate or raloxifene, Dr. Bruce Ettinger said at the meeting. “Physicians of these patients are waiting to prescribe new treatments, like teriparatide.” But based on the new data, “I'd steer away from concurrent treatment,” he told this newspaper. Sequential treatment with a single drug is less expensive and less complicated, said Dr. Ettinger, a senior investigator with the Kaiser Permanente Medical Care Program, Oakland, Ca. Dr. Ettinger reported on a Lilly-funded study of 33 women who were previously treated with alendronate and 26 who were previously treated with raloxifene. All were postmenopausal and had been diagnosed with osteoporosis; their average age was about 70 years. They were withdrawn from prior treatment and placed on a daily regimen of 20 µg teriparatide, given by self-administered, subcutaneous injection. After 6 months of teriparatide treatment, all patients showed evidence of activated bone turnover, based on serum markers. But measurement of bone mineral density showed a disparate response, depending on which prior treatment the women had received. Those who had used raloxifene showed the expected 5.5% average increase in bone density after 6 months of teriparatide treatment. But the average increase in bone density among the women who had used alendronate was 0.5%. The presence of alendronate may lead to undermineralization of new bone, he said. The second study, also funded by Lilly, involved 54 women with osteoporosis, aged 46-85 years, randomized to three groups: 22 women were treated only with 10 mg/day of alendronate for 18 months; 17 women were treated with placebo for the first 6 months, followed by teriparatide at a dose of 40 µg/day subcutaneously for 12 months; the remaining 15 women received a 10-mg/day dosage of alendronate from the start of the study, as well as a 40-µg/day injection of teriparatide that began 6 months after the start of the study. When bone mineral density was measured in a lateral projection of the vertebral spine after 18 months of treatment, the women treated with teriparatide alone had the largest increase in bone density, an average rise of 18%. Women treated with both alendronate and teriparatide had an average 12% rise in bone density, while those treated with alendronate alone had an average 4% increase, reported Dr. Robert M. Neer, director of the Osteoporosis Center at Massachusetts General Hospital in Boston. A similar interaction between alendronate and teriparatide was seen in a second arm of the study, which randomized 81 men with osteoporosis to the same three treatment groups, he said. © Copyright 2001, All Rights Reserved - Center
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