Bisphosphonates Use and Glucocorticoid Osteoporosis in Men

Study Compares 2 Osteoporosis Medications

Elderly man pouring pills into his handIn a study, researchers looked at 265 men who were among patients enrolled in 2 arms of a 1-year osteoporosis-focused, double-blind, randomized, controlled study.

Results of their findings were published in the January 2012 edition of Bone in the article “Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate.”

The mean age of the men was 56.4 years old, and the age range of all participants was 18 to 83 years old.

The study compared the impact of zoledronic acid (ZOL) and risedronate (RIS) in men who either started glucocorticoid therapy (prednisolone: 7.5mg/day or the equivalent), which was the prevention arm (n=88) or men who were continuing glucocorticoid therapy, which was the treatment arm (n=177).

At randomization, study participants had either a single 5 mg infusion of ZOL or took an oral daily dose of 5 mg of RIS. Throughout the duration of the study, participants in both groups took a daily dose of calcium (1,000 mg) and vitamin D (400 to 1,200 international units [IU]).

The primary endpoint for the study was a difference in percentage change from baseline in lumbar spine bone mineral density (BMD) at 12 months. Percentage changes in both total hip and femoral neck BMD, relative changes in bone turnover markers (β-CTx and P1NP), and overall safety were the secondary endpoints.

Researchers determined that in the treatment subpopulation, ZOL increased lumbar spine BMD by 4.7% vs 3.3% for RIS. At total hip, the percentage changes were 1.8% for ZOL vs 0.2% for RIS.

The research team noted that in the prevention subpopulation, bone loss was prevented with both osteoporosis medications. In this subpopulation, they found that at the lumbar spine, the percentage changes were 2.5% for ZOL vs -0.2% for RIS, and at the total hip, the percentage changes were 1.1% for ZOL vs -0.4% for RIS.

At 12 months—in both the prevention population (p=0.0024) and the treatment subpopulation (p=0.0232)—researchers also found that ZOL significantly increased lumbar spine BMD more than RIS.

Furthermore, at all points of time in the study, researchers observed that in the treatment subpopulation, ZOL had a significantly greater reduction in serum β-CTx and P1NP compared to RIS.

Additionally, in the prevention subpopulation, ZOL significantly reduced β-CTx at all points of time in the study. However, ZOL decreased P1NP at 3 months (p=0.0297) only.

Although there was a higher incidence of influenza-like illness and pyrexia events after infusion of ZOL, it was noted that both osteoporosis treatments were well tolerated in men.

At the end of the study, the research team concluded that ZOL given once a year either preserves or boosts bone mineral density overall within 1 year more than a daily dose of RIS in men who receive glucocorticoid therapy.

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