METABOLIC DISORDERS
Comparison of Bone Mineral Density in Lumbar Spine and Fracture Rate among Eight Drugs in Treatments of Osteoporosis in Men: A Network Meta-Analysis
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2015;3(15):5 PLoS One. 2015 May 26;10(5):e012803213 studies with a total of 3647 men were included in this meta-analysis to analyze the effect of eight drugs (alfacalcidol, alendronate, ibandronate, risedronate, zoledronate, strontium ranelate, teriparatide, and parathyroid hormone) on bone mass density (BMD) in the lumbar spine (LS) and fracture incidence in males with osteoporosis. Network meta-analysis based on direct and indirect comparisons demonstrated that zoledronate had the greatest efficacy in increasing BMD in LS when compared to placebo, and teriparatide had the greatest efficacy in reducing fracture rate when compared to placebo.
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
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はい = 1
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無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
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Introduction
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Accessing Data
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Analysing Data
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Results
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Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Osteoporosis is a common bone disease that results in decreased bone mass, and in turn significantly increases the risk of fracture. An improvement of bone mass density has been demonstrated to minimize the incidence of osteoporotic fractures. There have been a number of drugs which have been suggested to be efficacious in osteoporosis treatment, such as bisphosphonates (including alendronate, risedronate, ibandronate, and zoledronate), bone-anabolic drugs of parathyroid or teriparatide, strontium ranelate, and alfacalcidol, a vitamin D analog. Due to the wide range of drugs available, and conflicting results from many randomized controlled trials, the study sought to compare these options for primary treatment of osteoporosis.
主な研究課題は何ですか？
Between available drug therapies for osteoporosis (alfacalcidol, alendronate, ibandronate, risedronate, zoledronate, strontium ranelate, teriparatide, and parathyroid hormone) what is the hierarchy of efficacy with respect to improvement in bone mineral density of the lumbar spine and reduction of fracture rate?
重要な知見は？
- Compared to placebo, effect on lumbar spine BMD from greatest to lowest was zoledronate (SMD 13.48 [95% CrI 11.88 to 15.08]), alendronate (11.04 [9.68 to 12.41]), teriparatide (20mcg) + risedronate (10.98 [8.55 to 13.48]), risedronate (10.33 [8.68 to 12.01]), teriparatide (20mcg) (9.33 [6.87 to 11.76]), strontium ranelate (8.88 [7.51 to 10.24]), ibandronate (5.49 [3.82 to 7.16]), parathyroid hormone (4.89 [3.12 to 6.62]) and alfacalcidol (3.42 [1.7 to 5.2]).
- With the exception of teriparatide (20mcg) + risedronate, zoledronate demonstrated a significantly greater effect size on LS BMD when compared to all other treatment options.
- Compared to placebo, significantly lower fracture rates were demonstrated with treatment with teriparatide (20mcg) (4.04 [1.36 to 8.49]), teriparatide (40mcg) (3.5 [1.14 to 8.34]), zoledronate (2.92 [1.29 to 5.62]), and risedronate (OR 2.51 [95%CrI 1.23 to 4.24]).
- Alfacalcidol was associated with significantly higher fracture rate than treatment with risedronate (7.66, 1.74 to 19.27), zoledronate (8.41, 2.12 to 20.03), strontium ranelate (5.21, 1.32 to 11.88), teriparatide (40mcg) (10.49, 1.83 to 30.47), or teriparatide (20mcg) (12.12, 2.17 to 33.84)
最も覚えておくべきことは？
In osteoporosis treatment in men, zoledronate was associated with the greatest effect on lumbar spine bone mineral density relative to placebo treatment. Among the drug options, zoledronate, risedronate, and teriparatide (20 or 40mcg) demonstrated significant reductions in fracture incidence compared to placebo.
それが私の患者ケアにどのように影響するか？
The results of this study offer a preliminary analysis on the current evidence regarding effect of current drug options for osteoporosis on bone mineral density increase and fracture risk reduction. In general, zoledronate may be the most effective therapy drug for increasing lumbar BMD, whereas teriparatide may be associated with the greatest reduction in fracture rate. Nevertheless, results should be interpreted with careful consideration, as head-to-head comparisons between each drug are needed to ultimately conclude which treatment option offers the greatest efficacy for men with osteoporosis. Additional, future trials should consider safety analyses associated with the treatment options evaluated in the current study.
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