METABOLIC DISORDERS
Randomized controlled trial of zoledronic acid for treatment of osteoporosis in women
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(13):13 J Int Med Res. 2013 Jun;41(3):697-704. doi: 10.1177/0300060513480917. Epub 2013 May 13483 Chinese women with osteoporosis were randomized to receive one 5mg zoledronic acid (ZOL) intravenous infusion per year or a placebo. This two year study aimed to evaluate the effect of ZOL on fracture risk and bone mineral density. The results demonstrated increased bone mineral density in the total hip, femoral neck and trochanter with ZOL treatment. The overall risk of fracture was significantly reduced, compared to the placebo.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
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。
1/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
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 occurs in over 55% of the population over the age of 50 years. It compromises individual’s bone mineral density and exposes him or her to a higher risk of fractures. These fractures in the elderly can lead to increased morbidity, mortality and healthcare costs. Zoledronic acid, an aminobisphosphate, has shown positive effects on bone mineral density. This study was conducted to see if similar effects were present in mainland Chinese women.
主な研究課題は何ですか？
What is the effect of zoledronic acid (ZOL) on bone mineral density (BMD) and fracture risk at the L1-L4 vertebrae, femoral neck, hip and trochanter in Chinese women with osteoporosis, measured over 2 years?
重要な知見は？
- ZOL decreased fracture incidence at L1-L4 vertebrae, femoral neck, hip, and trochanter. However, a significant fracture risk decrease was only seen in the trochanter (p<0.05) and in overall fracture risk (46% difference, odds ratio 0.54, 95% CI 0.29 to 0.98).
- ZOL had greater BMD at all regions (L1-L4 vertebrae, total hip, femoral neck and trochanter) at all-time points (p<0.05).
- Serious adverse events and deaths were comparable between the two groups (3.3% in the ZOL group vs. 3.7 % in the placebo group). 6 patients (2.5%) in the ZOL group and 8 patients (3.3%) in placebo group experienced serious cardiac symptoms.
- First dose acute-phase reactions, such as headaches, chills, pyrexia, myalgia, arthralgia and influenza-like syndromes were similar between two groups (27.7% in the ZOL group and 25.3% in the placebo group).
- ZOL and placebo groups did not differ in serious incidences of atrial fibrillation, cardiac arrhythmia, and renal dysfunction.
最も覚えておくべきことは？
Annual infusions of 5mg Zoledronic acid safely increased bone mineral density in L1-L4 vertebrae, total hip, femoral neck, and trochanter. They also lowered trochanter and overall fracture risks at 2 years in Chinese women suffering from osteoporosis.
それが私の患者ケアにどのように影響するか？
The study recommends annual infusions of Zoledronic acid in treatment of women with osteoporosis. More blinded trials can further validate these findings.
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