Men's Osteoporosis Support GroupIV zoledronic acid for male osteoporosis J Bone Miner Res. 2010 Apr 30. [Epub ahead of print]. Efficacy and safety of a once-yearly i.v. infusion of zoledronic acid 5 mg versus a once-weekly 70 mg oral alendronate in the treatment of male osteoporosis: A randomized, multicenter, double-blind, active-controlled study. Orwoll E and others. PMID: 20499357. This two-year study used 5-mg i.v. zoledronic acid (ZOL), Reclast, for 302 men with osteoporosis. This was a parallel-group study where ZOL was compared to men taking once-weekly 70-mg alendronate (Fosamax). In this study design the ZOL group's results are compared, not to controls taking placebo, but to an active treatment group. The results are then tested for non-inferiority. That is, that ZOL, if effective, would be expected to give similar or superior results to those in the alendronate group for which several studies have already shown statistically significant results. Knowing that alendronate is effective to increase BMD and reduce fractures, it would be unethical to use a non-active control in the two-year study. The researchers found ZOL non-inferior to alendronate with a two-year 6.1% increase in spinal bone mineral density (BMD). They tested for several biochemical markers of bone formation and resorption, also finding comparable results between ZOL and alendronate. The authors concluded, "A once-yearly i.v. infusion of ZOL 5 mg increased bone density and decreased bone turnover markers similarly to once-weekly oral ALN 70 mg in men with low bone density." Editor's comments. There are several Updates on this site regarding zoledronic acid to treat postmenopausal osteoporosis. Here is one from 2007. To read others, type "zoledronate" or "zoledronic" in the FreeFind search engine. The once-yearly, 5-mg i.v. dose has been shown effective in treating women's osteoporosis, in fracture reduction, etc. And, in fact, it appears that a 5-mg dose may be effective for two years. Currently men would have to get Reclast as an off-label medication. I'm assuming this study will be used to get FDA approval of the medication for men, too, so expect to read about that in the fairly near future. This would be a very convenient form of dosing and would not require the man to take 52 pills per year and remain upright for 30-60 minutes and to not eat or drink any foods before taking the medication. Endocr Pract. 2010 May 24:1-23. [Epub ahead of print]. Zoledronic Acid Treatment of Osteoporosis: Effects in Men. Johnson DA and others. PMID: 20497935. This study involved 50 male veterans who had taken 4 mg i.v. injections of zoledronic acid for osteoporosis. Sixty-six percent of the men had taken bisphosphonates before taking zoledronic acid so they could be compared to the men whose first osteoporosis medication was zoledronic acid. Results were evaluated a mean of 2.2 years after receiving at least one i.v. injection. Results showed, "Larger increases in spine (6.7% v. 3.4%, p<0.05; per year: 2.8% v. 1.2%, p<0.01) and total hip BMD (3.2% v. 0.1%, p<0.03; per year: 1.3% v. 0.02%, p<0.02) occurred in bisphosphonate naïve patients compared with bisphosphonate exposed patients." The authors noted that these results are similar to those reported in clinical studies with alendronate in men and zoledronic acid in women. They concluded, "Our data suggest that 4 mg of intravenous zoledronic acid is an effective treatment for increasing BMD in a "real world" population of men with osteoporosis." Editor's comments. These results, with yearly spinal BMD increases of 6.7%, are quite good and compare favorably to the results of the Orwoll and others study discussed above. And the much greater increase in total hip BMD of 3.2% v. 0.1% is also quite noteworthy. Combined with the convenience of a once-yearly injection, and avoidance of the problem with taking a bisphosphonate once weekly all year long, zoledronic acid injections might be an osteoporosis therapy to discuss with your care provider. Anyone with gastrointestinal problems that might affect the absorption of oral medications should definitely consider this i.v. form of therapy for osteoporosis.
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