Dataset Information

Denosumab compared to bisphosphonates to treat postmenopausal osteoporosis: a meta-analysis.

ABSTRACT:

Background

The standard treatment for osteoporosis was controversial. Denosumab and bisphosphonates were two most common drugs. The purpose of this study was to compare the efficacy and safety of denosumab with bisphosphonates to treat osteoporosis.

Methods

Published literatures, only including randomized controlled trials (RCTs), were searched in the following electronic databases: PubMed, Embase, Web of Science, Cochrane Library, and Google database from inception to April 20 2018. Studies that compared denosumab with bisphosphonates to treat osteoporosis were included. Random-effect model was used for meta-analysis due to the unavoidable clinical heterogeneity. We used the risk of fracture as the primary outcome. Stata 12.0 was used for meta-analysis.

Results

Eleven studies involving 5446 patients (denosumab = 2873, bisphosphonates = 2573) were included in the present meta-analysis. There was no significant difference between the risk of fracture (risk ratio (RR), 1.13; 95% confidence interval (CI), 0.82-1.55; P = 0.466), adverse events (AEs) (RR 1.00; 95% CI 0.96-1.04; P = 0.957) and withdrawn due to AEs (RR 0.68; 95% CI 0.34-137; P = 0.280). Denosumab compared with bisphosphonates significantly increased change in total hip, femoral neck, lumbar spine, and one-third radius bone mineral density (BMD) for postmenopausal osteoporosis patients (P < 0.05).

Conclusions

Our meta-analysis suggested that denosumab but not bisphosphonates significantly increased change in total hip, femoral neck, lumbar spine, and one-third radius BMD for postmenopausal osteoporosis patients. Current evidence suggested no benefit of denosumab for reducing risk of fracture than bisphosphonates. More long-term follow-up RCTs are needed to identify the potential complications of denosumab.

SUBMITTER: Wu J

PROVIDER: S-EPMC6090940 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:To compare the efficacy of bazedoxifene and oral bisphosphonates for the prevention of nonvertebral fractures (NVFs) in women with higher risk of postmenopausal osteoporosis (i.e., the Fracture Risk Assessment Tool [FRAX] score ? 20%), based on currently available evidence from randomized controlled trials.Randomized controlled trials evaluating the NVF relative risk reduction (RRR) with oral bisphosphonates or bazedoxifene were identified by a systematic literature review and combined by means of a network meta-analysis. A subgroup of patients with a FRAX score of 20% or more in the bazedoxifene phase III osteoporosis study was selected as the population of interest on the basis of the bazedoxifene label. In one analysis (analysis 1), the placebo response of the subgroup with a FRAX score of 20% or more was the benchmark to select comparable bisphosphonate trials. Additional analyses incorporated the aggregate data from the bisphosphonate trials with all the FRAX subgroups (analysis 2) or with the individual patient data from the bazedoxifene trial (analysis 3).Nine identified bisphosphonate trials (alendronate, ibandronate, risedronate; N = 23,440 patients) with a similar placebo response as observed for the subgroup of high risk patients in the bazedoxifene trial were included in analysis 1. The results of the network meta-analysis of this study set suggest that bazedoxifene is expected to have an RRR of 0.43 (95% credible interval [CrI] -0.19 to 0.72) versus alendronate, 0.58 (95% CrI 0.05-0.81) versus ibandronate, and 0.39 (95% CrI -0.29 to 0.70) versus risedronate. Analyses in which treatment effects with bisphosphonates were projected to a population with a FRAX score of 20% or more with meta-regression approaches (analysis 2 and analysis 3) provide similar findings.Based on an indirect comparison of randomized trials, bazedoxifene is expected to have at least a comparable RRR of NVF as alendronate, ibandronate, and risedronate in women with higher risk of postmenopausal osteoporosis.