Efficacy and security of once-yearly zoledronic acid in Japanese sufferers with main osteoporosis: two-year outcomes from a randomized placebo-controlled double-blind research (ZOledroNate remedy in Efficacy to osteoporosis; ZONE research).
Osteoporos Int. 2017 Jan;28(1):389-398
Authors: Nakamura T, Fukunaga M, Nakano T, Kishimoto H, Ito M, Hagino H, Sone T, Taguchi A, Tanaka S, Ohashi M, Ota Y, Shiraki M
In a 2-year randomized, placebo-controlled research of 665 Japanese sufferers with main osteoporosis, once-yearly administration of zoledronic acid (5 mg) diminished the chance of latest morphometric vertebral fractures.
INTRODUCTION: The aim of this research was to find out the efficacy and security of once-yearly intravenous infusion of ZOL in Japanese sufferers with main osteoporosis.
METHODS: This was a two-year multicenter, randomized, placebo-controlled, double-blind, parallel-group comparative research (ZONE Examine). Topics had been 665 Japanese sufferers between the ages of 65 and 89 years who had prevalent vertebral fracture. Topics had been randomly assigned to obtain once-yearly intravenous infusion of 5 mg of ZOL or placebo at baseline and 12 months.
RESULTS: The two-year incidence of latest morphometric vertebral fracture was three.Zero % (10/330 topics) within the ZOL group and eight.9 % (29/327) within the placebo group (p = Zero.0016). The 24-month cumulative incidence of latest morphometric vertebral fracture was three.three % within the ZOL group versus 9.7 % within the placebo group (log-rank check: p = Zero.0029; hazard ratio: Zero.35; 95 % confidence interval: Zero.17-Zero.72). The cumulative incidence of any scientific fracture, scientific vertebral fracture, and non-vertebral fracture was considerably diminished within the ZOL group by 54, 70, and 45 %, respectively, in comparison with the placebo group. At 24 months, ZOL administration elevated bone mineral density within the lumbar backbone, femoral neck, and complete hip (t check: p < Zero.0001). No new antagonistic occasions or osteonecrosis of the jaw had been noticed on this research.
CONCLUSIONS: As soon as-yearly administration of ZOL 5 mg to Japanese sufferers with main osteoporosis diminished the chance of latest morphometric vertebral fractures and was discovered to be secure.
PMID: 27631091 [PubMed – indexed for MEDLINE]