The effects of intravenous zoledronic acid in Chinese women with postmenopausal osteoporosis

Abstract

The aim of this study was to assess the efficacy and safety of a once-yearly zoledronic acid treatment for Chinese women with postmenopausal osteoporosis in Taiwan and Hong Kong. This post hoc subpopulation analysis, from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly Pivotal Fracture Trial, enrolled 323 Chinese women with osteoporosis who were randomly given either annual infusions of zoledronic acid or placebo for 3 consecutive years. The incidence of fractures and changes in bone mineral density (BMD) were measured; adverse events (AEs) and tolerability were recorded and assessed. The results of this study at 36 months demonstrate that there was a significantly reduced risk of morphometric vertebral fracture and clinical vertebral fracture in subjects treated with zoledronic acid (P < 0.05). In addition, there were significant increases of BMD by 4.9%, 4.3%, and 7.0% in the total hip, femoral neck, and trochanter, respectively, in the zoledronic acid group compared with the placebo group (P < 0.001 for all comparisons). The incidences of AEs were comparable between the two groups. Thus, once-yearly zoledronic acid treatment showed bone protection effects by reducing the risk of vertebral fracture and increasing BMD in Chinese women with postmenopausal osteoporosis.

Kwas zoledronowy stosowany przez dwa lata u Chinek z osteoporozą pomenopauzalną zwiększa gęstość mineralną tkanki kostnej i poprawia jakość życia związaną ze stanem zdrowia

“…A lot of studies have confirmed the benefit of once-yearly ZOL 5 mg. They have demonstrated that ZOL significantly reduces the risk of morphometric vertebral fracture and clinical vertebral fracture, and increases total hip, femoral neck, and trochanter BMD [12,15,22,23]. A few studies have …”

“…pointed out that the increasing effect of ZOL on bone mineral density would continue with the increasing time of injections [22,24]. So we supposed that over a two-year period, use of once-yearly ZOL 5 mg, BMD would continue to show improvements.…”

Summary of AHRQ’s Comparative Effectiveness Review of Treatment to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis: Update of the 2007 Report

“…However, the reviewers identified only 1 RCT that compared the effect of sex on the response to treatment, 17 and therefore graded as insufficient the evidence from this RCT that calcium and vitamin D3 decreased the risk of fracture in elderly women but not in elderly men. 18 Differences in response to treatment according to race or ethnicity were also evaluated as is common in analyses of population subgroups. Although they found high strength of evidence for decreased vertebral fractures specifically among Asian women treated with raloxifene, these findings were similar to that of U.S. and other international populations.…”

“…Although they found high strength of evidence for decreased vertebral fractures specifically among Asian women treated with raloxifene, these findings were similar to that of U.S. and other international populations. 18,19 The evidence was graded insufficient at the time of this AHRQ review to assess the effect of renal function on the efficacy of therapies except treatment with zoledronic acid, 20 in which impaired renal function reduced the efficacy of zoledronic acid in preventing vertebral (but not hip or other nonvertebral) fractures. 21 …”

Design of a Multicenter, Randomized, Open Label, Parallel Group Study to Evaluate the Efficacy of Loxoprofen on Acute-Phase Reactions in Japanese Primary Osteoporosis Patients Treated with Zoledronic Acid

“…The Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Pivotal Fracture Trial (HORIZON-PFT) and subsequent sub-analyses have shown a higher incidence of APRs in the Asian populations compared to those in the multinational populations included in the studies [1,3,4]. A sub-analysis of the HORIZON-PFT showed that the incidences of pyrexia and arthralgia in the Chinese population were higher than those in the multinational population, of which 14.2% were Asians (pyrexia, 28.2 vs. 16.1%; arthralgia, 21.5 vs.…”