Dataset Information

Comparison of Denosumab and Bisphosphonates in Patients With Osteoporosis: A Meta-Analysis of Randomized Controlled Trials.

ABSTRACT: CONTEXT:It is uncertain which osteoporosis therapy is more effective: bisphosphonates or denosumab. OBJECTIVE:To determine whether denosumab therapy increases bone mineral density (BMD) and reduces fracture risk more so than bisphosphonates in patients with low BMD or osteoporosis. METHODS:The PubMed, Embase, and the Cochrane Library databases were searched through November 2018 for head-to-head, randomized, controlled trials comparing denosumab and bisphosphonates among adult patients with low BMD or osteoporosis. Random-effects models were used. RESULTS:We identified 10 eligible trials including 5361 participants. Denosumab increased BMD more than bisphosphonate at 12 months (mean difference, 1.42%; 95% CI, 0.95% to 1.89%; P < 0.001) at lumbar spine, 1.11% (95% CI, 0.91% to 1.30%; P < 0.001) at total hip, and 1.00% (95% CI, 0.78% to 1.22%; P < 0.001) at femoral neck. At 24 months, the respective increase differences were 1.74% (95% CI, 1.05% to 2.43%; P < 0.001), 1.22% (95% CI, 0.66% to 1.77%; P < 0.001), and 1.19% (95% CI, 0.65% to 1.72%; P < 0.001). There was no difference in fracture end point at 12 months, but denosumab had a lower osteoporotic fracture incidence than alendronate at 24 months (risk ratio, 0.51; 95% CI, 0.27 to 0.97). CONCLUSION:Denosumab improved BMD significantly more than bisphosphonate treatment at the lumbar spine, total hip, and femoral neck at 12 and 24 months. Only one study demonstrated greater osteoporotic fracture reduction with denosumab treatment. Longitudinal studies with longer follow-up and large sample size are needed to confirm the efficacy difference.

SUBMITTER: Lyu H

PROVIDER: S-EPMC6447951 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Comparison of Denosumab and Bisphosphonates in Patients With Osteoporosis: A Meta-Analysis of Randomized Controlled Trials.

Lyu Houchen H Jundi Bakr B Xu Chang C Tedeschi Sara K SK Yoshida Kazuki K Zhao Sizheng S Nigwekar Sagar U SU Leder Benjamin Z BZ Solomon Daniel H DH

The Journal of clinical endocrinology and metabolism 20190501 5

<h4>Context</h4>It is uncertain which osteoporosis therapy is more effective: bisphosphonates or denosumab.<h4>Objective</h4>To determine whether denosumab therapy increases bone mineral density (BMD) and reduces fracture risk more so than bisphosphonates in patients with low BMD or osteoporosis.<h4>Methods</h4>The PubMed, Embase, and the Cochrane Library databases were searched through November 2018 for head-to-head, randomized, controlled trials comparing denosumab and bisphosphonates among ad ...[more]

PMID: 30535289

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Project description:IntroductionBisphosphonates (BPs) are first-line therapy for osteoporosis. Adherence is usually low in chronic, asymptomatic diseases, but gastrointestinal (GI) side-effects can also contribute to low adherence in BP therapy and may necessitate a review by a gastroenterologist with or without gastroscopy.AimsOur meta-analysis aims to determine the risk of severe GI adverse events due to oral BP therapy in osteoporotic patients.MethodsA systematic search was conducted in three databases up to September 2020 for randomized controlled trials (RCTs) detailing GI adverse events in adults with osteoporosis on BP compared to placebo. Risk ratios (RRs) with 95% confidence intervals (CI) were calculated for non-severe and severe adverse events indicating endoscopic procedure with the random-effects model. Statistical heterogeneity was assessed using chi2 and I2 statistics.ResultsForty-two RCTs with 39,047 patients with 9,999 non-severe and 1,503 severe GI adverse events were included. The incidence of non-severe and severe adverse events ranged between 0.3-54.9 and 0-10.3%, respectively. There was no difference between BP and control groups in terms of the risk of non-severe or severe side effects: RR=1.05 (CI: 0.98-1.12), I2 = 48.1%, and RR=1.01 (CI: 0.92-1.12), I2 = 0.0%, respectively. Subgroup analysis of the most commonly used BP, once-weekly alendronate 70 mg, revealed an association between bisphosphonates and the risk of non-severe GI adverse events, RR=1.16 (CI: 1.00-1.36), I2 = 40.7%, while the risk of severe GI side effects was not increased in this subgroup, RR=1.20 (CI: 0.83-1.74), I2 = 0.0%.ConclusionOur results show that bisphosphonates do not increase the risk of severe GI adverse events. However, the marked variability of the screening for side effects in the included studies, and the fact that in most of the studies GI diseases were exclusion criteria limits the strenght of evidence of our results. The conclusions drawn from the meta-analysis are therefore restricted to selected populations, and the results must be interpreted with caution.

Dataset Information

Comparison of Denosumab and Bisphosphonates in Patients With Osteoporosis: A Meta-Analysis of Randomized Controlled Trials.

Publications

Comparison of Denosumab and Bisphosphonates in Patients With Osteoporosis: A Meta-Analysis of Randomized Controlled Trials.

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