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By Gene Emery
BOSTON (Reuters) - People treated with Amgen Inc.'s experimental drug denosumab twice a year can strengthen the density of bones in the spine, a study said.
The formal results of the first year of the test, published in Thursday's New England Journal of Medicine, come three months after Amgen reported on the effects of the drugs after two years of use as part of the same study.
The 412 volunteers, who were all women with low bone density, were given the drug -- at one of seven doses -- or either a placebo or the Merck & Co. drug Fosamax, also known as alendronate.
After one year of treatment, denosumab, formerly known as AMG 162, was found to increase bone density at the lumbar portion of the spine by 3.0 percent to 6.7 percent. Density measurements in other bones also improved.
In November, the company announced that at the two-year mark, the increase ranged from 4.3 percent to 9.0 percent.
The results were comparable to those seen for Fosamax, which produced a 4.6 percent increase at the one-year point. Volunteers who received a placebo lost bone in the spine.
Amgen paid for the study, designed it, holds the data and conducted the statistical analysis.
No serious side effects were reported.
An advantage of denosumab may be its persistence in the body. Only about one in four women given drugs to prevent osteoporosis actually take them regularly. Doctors would welcome a drug that only needs to be taken two or four times a year. Fosamax is taken once a week.
The research team, led by Michael McClung of the Providence Portland Medical Center in Portland, Oregon, found that the best result came among women who got a 60 milligram injection of denosumab once every six months.
In an editorial in the journal, Michael Whyte of the Shriners Hospital for Children in St. Louis, said other long-acting drugs were also being developed for osteoporosis, including zoledronic acid, which may turn out to work if given once per year.
About 10 million Americans have osteoporosis, and four out of five are women.
By Gene Emery
BOSTON (Reuters) - People treated with Amgen Inc.'s experimental drug denosumab twice a year can strengthen the density of bones in the spine, a study said.
The formal results of the first year of the test, published in Thursday's New England Journal of Medicine, come three months after Amgen reported on the effects of the drugs after two years of use as part of the same study.
The 412 volunteers, who were all women with low bone density, were given the drug -- at one of seven doses -- or either a placebo or the Merck & Co. drug Fosamax, also known as alendronate.
After one year of treatment, denosumab, formerly known as AMG 162, was found to increase bone density at the lumbar portion of the spine by 3.0 percent to 6.7 percent. Density measurements in other bones also improved.
In November, the company announced that at the two-year mark, the increase ranged from 4.3 percent to 9.0 percent.
The results were comparable to those seen for Fosamax, which produced a 4.6 percent increase at the one-year point. Volunteers who received a placebo lost bone in the spine.
Amgen paid for the study, designed it, holds the data and conducted the statistical analysis.
No serious side effects were reported.
An advantage of denosumab may be its persistence in the body. Only about one in four women given drugs to prevent osteoporosis actually take them regularly. Doctors would welcome a drug that only needs to be taken two or four times a year. Fosamax is taken once a week.
The research team, led by Michael McClung of the Providence Portland Medical Center in Portland, Oregon, found that the best result came among women who got a 60 milligram injection of denosumab once every six months.
In an editorial in the journal, Michael Whyte of the Shriners Hospital for Children in St. Louis, said other long-acting drugs were also being developed for osteoporosis, including zoledronic acid, which may turn out to work if given once per year.
About 10 million Americans have osteoporosis, and four out of five are women.