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An annual intravenous infusion of zoledronic acid reduced the rate of new clinical fractures and improved survival in patients who had recently undergone surgery for a hip fracture, according to Dr. Kenneth W. Lyles and associates in the HORIZON Recurrent Fracture Trial.
The Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) study, supported by Novartis, is an international clinical trial that compared the potent bisphosphonate with placebo in 2,127 patients followed for a mean of 2 years, the investigators reported on the New England Journal of Medicine Web site. “No other controlled clinical trial has previously shown efficacy of any osteoporosis medication for reducing the recurrence of fracture in patients who already had a broken hip,” Dr. Karim Calis and Dr. Frank Pucino wrote in an editorial accompanying the report.
All subjects sustained a hip fracture after minimal trauma and underwent surgical repair, then received their first intravenous infusion within 90 days. They received daily oral calcium and vitamin D supplements, and were allowed concomitant therapy with nasal calcitonin, selective estrogen receptor modulators, hormone therapy, tibolone, or external hip protectors. A total of 1,065 patients were randomly assigned to IV zoledronic acid and 1,062 to IV placebo once yearly. Mean age was 74 years.
A total of 424 new clinical fractures occurred during follow-up. The rate was 8.6% with zoledronic acid and 13.9% with placebo, for a reduction in relative risk of 35%, said Dr. Lyles, of Duke University Medical Center, Durham, N.C. A total of 242 subjects died. Mortality was 9.6% with zoledronic acid and 13.3% with placebo, for a significant 28% relative risk reduction.
Bone mineral density (BMD) at the hip increased 2.6% at 1 year, 4.7% at 2 years, and 5.5% at 3 years in the zoledronic acid group. In the placebo group it fell 1.0%, 0.7%, and 0.9%, respectively. BMD at the femoral neck increased 0.8%, 2.2%, and 3.6% in the zoledronic acid group. It declined in the placebo group 1.0%, 0.7%, and 0.9%. All differences were significant (N. Engl. J. Med. 2007 Sept. 17 [Epub doi:10.1056/NEJMoa074941]).
Rates of overall adverse events and serious adverse events were similar. There were no differences in frequencies of cardiovascular adverse effects nor in rates of renal toxic effects. There were no cases of osteonecrosis of the jaw, which research suggested might be tied to zoledronic acid. There was no evidence of delayed bone healing, either.
In their comment, Dr. Calis and Dr. Pucino, both of the National Institutes of Health, Bethesda, Md., wrote, “Zoledronic acid appears to offer several advantages over other potential therapies, with one important caveat: Although the risk-benefit pendulum has now swung in favor of treatment, additional long-term safety data are essential,” (N. Engl. J. Med. 2007 Sept. 17 [Epub10.10565/N EJMe078192]). Future studies should compare treatment with other therapies and address physical function, quality of life, and cost-effectiveness, they added.
ELSEVIER GLOBAL MEDICAL NEWS
An annual intravenous infusion of zoledronic acid reduced the rate of new clinical fractures and improved survival in patients who had recently undergone surgery for a hip fracture, according to Dr. Kenneth W. Lyles and associates in the HORIZON Recurrent Fracture Trial.
The Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) study, supported by Novartis, is an international clinical trial that compared the potent bisphosphonate with placebo in 2,127 patients followed for a mean of 2 years, the investigators reported on the New England Journal of Medicine Web site. “No other controlled clinical trial has previously shown efficacy of any osteoporosis medication for reducing the recurrence of fracture in patients who already had a broken hip,” Dr. Karim Calis and Dr. Frank Pucino wrote in an editorial accompanying the report.
All subjects sustained a hip fracture after minimal trauma and underwent surgical repair, then received their first intravenous infusion within 90 days. They received daily oral calcium and vitamin D supplements, and were allowed concomitant therapy with nasal calcitonin, selective estrogen receptor modulators, hormone therapy, tibolone, or external hip protectors. A total of 1,065 patients were randomly assigned to IV zoledronic acid and 1,062 to IV placebo once yearly. Mean age was 74 years.
A total of 424 new clinical fractures occurred during follow-up. The rate was 8.6% with zoledronic acid and 13.9% with placebo, for a reduction in relative risk of 35%, said Dr. Lyles, of Duke University Medical Center, Durham, N.C. A total of 242 subjects died. Mortality was 9.6% with zoledronic acid and 13.3% with placebo, for a significant 28% relative risk reduction.
Bone mineral density (BMD) at the hip increased 2.6% at 1 year, 4.7% at 2 years, and 5.5% at 3 years in the zoledronic acid group. In the placebo group it fell 1.0%, 0.7%, and 0.9%, respectively. BMD at the femoral neck increased 0.8%, 2.2%, and 3.6% in the zoledronic acid group. It declined in the placebo group 1.0%, 0.7%, and 0.9%. All differences were significant (N. Engl. J. Med. 2007 Sept. 17 [Epub doi:10.1056/NEJMoa074941]).
Rates of overall adverse events and serious adverse events were similar. There were no differences in frequencies of cardiovascular adverse effects nor in rates of renal toxic effects. There were no cases of osteonecrosis of the jaw, which research suggested might be tied to zoledronic acid. There was no evidence of delayed bone healing, either.
In their comment, Dr. Calis and Dr. Pucino, both of the National Institutes of Health, Bethesda, Md., wrote, “Zoledronic acid appears to offer several advantages over other potential therapies, with one important caveat: Although the risk-benefit pendulum has now swung in favor of treatment, additional long-term safety data are essential,” (N. Engl. J. Med. 2007 Sept. 17 [Epub10.10565/N EJMe078192]). Future studies should compare treatment with other therapies and address physical function, quality of life, and cost-effectiveness, they added.
ELSEVIER GLOBAL MEDICAL NEWS
An annual intravenous infusion of zoledronic acid reduced the rate of new clinical fractures and improved survival in patients who had recently undergone surgery for a hip fracture, according to Dr. Kenneth W. Lyles and associates in the HORIZON Recurrent Fracture Trial.
The Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) study, supported by Novartis, is an international clinical trial that compared the potent bisphosphonate with placebo in 2,127 patients followed for a mean of 2 years, the investigators reported on the New England Journal of Medicine Web site. “No other controlled clinical trial has previously shown efficacy of any osteoporosis medication for reducing the recurrence of fracture in patients who already had a broken hip,” Dr. Karim Calis and Dr. Frank Pucino wrote in an editorial accompanying the report.
All subjects sustained a hip fracture after minimal trauma and underwent surgical repair, then received their first intravenous infusion within 90 days. They received daily oral calcium and vitamin D supplements, and were allowed concomitant therapy with nasal calcitonin, selective estrogen receptor modulators, hormone therapy, tibolone, or external hip protectors. A total of 1,065 patients were randomly assigned to IV zoledronic acid and 1,062 to IV placebo once yearly. Mean age was 74 years.
A total of 424 new clinical fractures occurred during follow-up. The rate was 8.6% with zoledronic acid and 13.9% with placebo, for a reduction in relative risk of 35%, said Dr. Lyles, of Duke University Medical Center, Durham, N.C. A total of 242 subjects died. Mortality was 9.6% with zoledronic acid and 13.3% with placebo, for a significant 28% relative risk reduction.
Bone mineral density (BMD) at the hip increased 2.6% at 1 year, 4.7% at 2 years, and 5.5% at 3 years in the zoledronic acid group. In the placebo group it fell 1.0%, 0.7%, and 0.9%, respectively. BMD at the femoral neck increased 0.8%, 2.2%, and 3.6% in the zoledronic acid group. It declined in the placebo group 1.0%, 0.7%, and 0.9%. All differences were significant (N. Engl. J. Med. 2007 Sept. 17 [Epub doi:10.1056/NEJMoa074941]).
Rates of overall adverse events and serious adverse events were similar. There were no differences in frequencies of cardiovascular adverse effects nor in rates of renal toxic effects. There were no cases of osteonecrosis of the jaw, which research suggested might be tied to zoledronic acid. There was no evidence of delayed bone healing, either.
In their comment, Dr. Calis and Dr. Pucino, both of the National Institutes of Health, Bethesda, Md., wrote, “Zoledronic acid appears to offer several advantages over other potential therapies, with one important caveat: Although the risk-benefit pendulum has now swung in favor of treatment, additional long-term safety data are essential,” (N. Engl. J. Med. 2007 Sept. 17 [Epub10.10565/N EJMe078192]). Future studies should compare treatment with other therapies and address physical function, quality of life, and cost-effectiveness, they added.
ELSEVIER GLOBAL MEDICAL NEWS