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Zoledronate provided long-lasting bone turnover, density in HIV-infected men
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The effects of two annual 4-mg doses of intravenous zoledronate in HIV-infected men linger for at least 5 years after the second dose, according to findings of an extended trial.
"The current study has some limitations. It is a small study, although the narrow confidence intervals around the changes in bone turnover and [bone mineral density] suggest that the findings are robust," researchers wrote in the study.
Mark J. Bolland, MBChB, PhD, a researcher with the Bone and Joint Research Group in the department of medicine at the University of Auckland, New Zealand, and colleagues designed a 4-year extension of a 2-year, double blind, randomized, placebo-controlled trial that included 43 HIV-infected men.
All participants had a BMD T-score of less than -0.5, and 35 participants entered the unmasked, open-ended extension study.
According to the study, markers of bone formation and resorption not only showed sustained and stable suppression, but also the BMD remained stable between 1 and 5 years after the second dose of zoledronate (Zometa, Novartis) was administered.
After the first infusion of zoledronate, researchers reported that urine N-telopeptide of type 1 collagen decreased by 63% at 3 months. Further data collected by the researchers indicate that changes in BMD between the placebo and zoledronate groups during 6 years were significant (P<.02). Between 2 and 6 years, BMD was greater at the lumbar spine by 3.7% (95% CI, 0.3-7.0), 2.3% at the total hip (95% CI, 0.3-4.3) and 2.5% (95% CI, 0.8-4.1) at the total body.
Five years after the second dose, differences between groups were 3.4% (95% CI, 1.4-5.4) for total hip BMD and 1.6% (95% CI, 0.2-3.1) for total body BMD.
The effect of baseline vitamin D levels were also evaluated, but results provided no significant differences between the zoledronate and placebo group.
Additional data suggest that lower doses and infrequent dosage intervals may offer cost-savings while providing an effective alternative therapy.
Disclosure: One of the study researchers reports receiving research funding and speaker and consultancy fees from Novartis. All other researchers report no relevant financial disclosures.
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