Clinical Rounds
I N T E R N A L M E D I C I N E N E W S • S e p t e m b e r 1 5 , 2 0 0 6 Risedronate Gains Approval for Male Osteoporosis B Y N A N C Y W A L S H
porosis,” said Dr. Petak, who is director of The Food and Drug Administration porosis center at the Texas Institute for Re- 2.2%, respectively, were seen in the control tions for males, this approval will enable groups was statistically significant, Dr.
osteoporosis is 35 mg taken once a week.
patients in the risedronate-treated patients Risedronate, an oral bisphosphonate first ages of 36 and 84 to receive either 35 mg risedronate once a week, or placebo. Dur- months, respectively, while a mean change ing the study, all patients received daily of 0.4% seen in controls at 12 months re- ticoid-induced osteoporosis and Paget’s differences, too, were statistically signifi- disease. It is the second of the three oral statistically significant difference of 4.53% those receiving only the vitamin D and cal- Neglected bones: About 2 million U.S.
men reportedly have osteoporosis.
fractures. By 2 years, with 14 and 35 new to in June, was the largest thus far to eval- Significant differences also were seen in fractures in the two groups, respectively, uate antiresorptive therapy for idiopathic fracture risk reduction was 61% for those osteoporosis in men, and the first to use events. Again, the safety is similar to what trochanter at months 12 and 24 and at the to the trial’s principal investigator, Dr.
for Better Bone Health (Procter & Gamble “Osteoporosis in men is still widely ne- type I collagen C-telopeptide, type I col- Pharmaceuticals and Sanofi-Aventis U.S.).
lagen N-telopeptide/creatinine, and bone- In 2000, risedronate at a 5-mg oral daily about 2 million men have the condition.
therapy in a prospective open-label trial dose was approved for preventing and treat- ing glucocorticoid-induced osteoporosis in out the study. “Beginning at the first mea- were below –2.5 at the lumbar spine and porosis but are close to developing it, the below –2.0 at the femoral neck, Dr. Johann treatment with systemic glucocorticoids. It is also approved for treating and preventing million,” he said at the congress.
A total of 158 of the patients received 5 mg risedronate, plus 1,000 mg calcium and women,” Dr. Boonen said in an interview. 800 IU vitamin D, daily for 2 years. Among every day, and for treating Paget’s disease teoporosis and to treat those at risk for of the bone at an oral dose of 30 mg once fractures,” added Dr. Boonen, professor of dronate and those receiving placebo, with were given the alfacalcidol form of vita- and 73% of the groups, respectively. A to- ly, while those without vertebral fractures were treated with 800 IU plain vitamin D, gists, welcomed the approval. “It is of Single-Dose Zoledronic Acid Effective, Safe in Osteoporosis B Y N A N C Y W A L S H
gen (NTx) fell from 46.1 to 15.2 nmol bone chest pain) and by three patients in the al- endronate group (one patella fracture and T O R O N T O — A single intravenous dose the alendronate group at 1 week. This rel- ative change from baseline in NTx was sig- zoledronic acid group and 86% of those in Dr. Kenneth Saag reported in a poster ses- Zoledronic acid is
pants expressing a “strong preference” for sion at a world congress on osteoporosis.
the most powerful
weekly regimen (66% versus 20%), Dr.
available, and its
long duration of
effect now has
been shown.
aged 45-79 years to a single infusion of 5 adverse events during the 3 days following ogy, University of Alabama, Birmingham.
preference for the single-dose treatment, received oral placebo, and those receiving according to Dr. Lindsay of the clinical re- the adverse event rates were similar in the search center, Helen Hayes Hospital, West line through week 24 in both groups.
While reductions in BASP levels were sig- cross-linked N-telopeptide of type I colla- nificantly greater in the zoledronic acid two patients in the zoledronic acid group


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