Preventing Glucocorticoid-induced Osteoporosis in Men
New Research Compares 2 Bisphosphonates
Researchers examined 265 men who were among patients who participated in 2 arms of a double-blind, randomized, controlled trial. The study looked at bisphosphonates—specifically 2 types of osteoporosis medications—and preventing glucocorticoid osteoporosis in these men.
The results of their study were published in the January 2012 edition of Bone in an article called “Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate.”
The mean age of the men in the study was 56.4 years old, but ages ranged from 18 to 83 years old.
For the purposes of this study, researchers compared the effects of zoledronic acid (ZOL) and risedronate (RIS) in participants who either just began glucocorticoid therapy (the men took 7.5 mg/day or the equivalent of prednisolone) or participants who were continuing glucocorticoid therapy. The men who just began glucocorticoid treatment were a part of the prevention arm (n=88), and the men who were continuing glucocorticoid were a part of the treatment arm (n=177).
Study participants received either a single 5 mg infusion of ZOL or they took an oral daily dose of 5 mg of RIS at randomization. In addition to these medications, the men in both groups took daily doses of calcium (1,000 mg) and vitamin D (400 to 1,200 international units [IU]).
Difference in percentage change from baseline in bone mineral density (BMD) at 12 months in the lumbar spine was the primary endpoint. The secondary endpoints were the percentage changes in BMD in both the total hip and femoral neck, relative changes in bone turnover markers (both β-CTx and P1NP), and the overall safety.
It was noted that in the treatment subpopulation, ZOL increased lumbar spine BMD by 4.7% vs 3.3% for RIS, and at the total hip, percentage changes were 1.8% (ZOL) vs 0.2% (RIS).
The research team also noted that in the prevention subpopulation, bone loss was prevented with both osteoporosis medications. Also in this subpopulation, percentage changes were 2.5% (ZOL) vs -0.2% (RIS) in the lumbar spine, and percentage changes were 1.1% (ZOL) vs -0.4% (RIS) in the total hip.
Researchers discovered that at 12 months, ZOL significantly increased lumbar spine BMD more than RIS in the prevention population (p=0.0024) and the treatment subpopulation (p=0.0232).
In addition, in the treatment subpopulation, ZOL had a significantly greater decrease in serum β-CTx and P1NP than RIS at all points of time in the study.
They also found that in the prevention subpopulation, ZOL significantly decreased β-CTx at all points of time in the study, but ZOL decreased P1NP at 3 months (p=0.0297) only.
It was observed that both of the osteoporosis treatments were well tolerated by the participants—although there was a higher incidence of influenza-like illness and pyrexia events after infusion of ZOL.
The research team concluded that in men who receive glucocorticoid therapy, ZOL administered once a year can preserve or boost bone mineral density—including BMD of the lumbar spine—within 1 year more than a daily dose of RIS.