GENERAL ORTHOPAEDICS
Duration of Antiresorptive Effects of Low‐Dose Zoledronate in Osteopenic Postmenopausal Women: A Randomized, Placebo‐Controlled Trial
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by one or more authors of the
original publication.
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(8):10 J Bone Miner Res. 2014 Jan;29(1):166-72. doi: 10.1002/jbmr.2009.180 postmenopausal women with osteopenia were randomly allocated to receive either 1mg, 2.5 mg, or 5 mg intravenous infusion of zoledronate or a placebo. The purpose of this trial was to determine the optimal dosing regimen of zoledronate. Results indicated that a single administration of a 1 mg or 2.5 mg dose of intravenous zoledronate produces antiresorptive effects for at least two years, although the 1 mg antiresorptive effects appear to slow after 12 months. At 2 years post-intervention, the change in bone mineral density (BMD) and bone turnover markers in the 2.5 mg dose group were similar to effects induced by 5 mg.
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。
4/4
Randomization
4/4
Outcome Measurements
3/4
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？
While it has been observed that annual intravenous administration of 5 mg of zoledronate may reduce the risk of fractures in osteoporosis patients and decrease mortality in hip fracture patients, the optimal dosing regimen of zoledronate remains ambiguous. Previously, it was found that a single administration of 1 mg and 2.5 mg zoledronate significantly decreased markers of bone turnover and increased bone mineral density after 1 year. Due to recent insight regarding potential long-term antiresorptive effects following single dose drug administration, the aim of this study was to investigate this topic at a follow-up of 2 years post-intervention.
主な研究課題は何ですか？
What are the effects of a single intravenous administration of either 1 mg, 2.5 mg, or 5 mg zoledronate on bone mineral density and bone turnover markers after 2 years?
重要な知見は？
- Bone mineral density (BMD) was higher in the zoledronate groups than the placebo group at each site and each time point during the trial (all p<0.0001).
- Change in lumbar spine BMD 2 years after a single administration of zoledronate was greater in the zoledronate groups than the placebo group, data expressed as mean (95% CI) percent difference than values in the placebo group [4.4% (2.7% to 6.1%) with 1 mg, 5.5% (3.9% to 7.2%) with 2.5 mg, and 5.3% (3.8% to 6.7%) with 5 mg] (for each dose, p<0.001).
- Change in total hip BMD 2 years after a single administration of zoledronate was greater in the zoledronate groups than the placebo group [2.6% (1.5% to 3.7%) with 1 mg, 4.4% (3.5% to 5.3%) with 2.5 mg; 4.7% (3.7% to 5.7%) with 5 mg] (for each dose, p<0.001).
- Change in the bone turnover marker Beta-CTX 2 years after a single administration of zoledronate was [-18% (-30% to -7%) with 1 mg, -45% (-54% to -35%) with 2.5 mg, and -51% (-60% to -42%) with 5 mg]. Throughout the trial the value of Beta-CTX in the 2.5 and 5 mg dose groups was significantly lower than the placebo group (p<0.0001). In the 1 mg dose group, the values of Beta-CTX were lower than placebo group values until 18 months.
- Change in the bone turnover marker P1NP 2 years after a single administration of zoledronate was [-15% (-26% to -4%) with 1 mg, -28% (-39% to -17%) with 2.5 mg, and -29% (-40% to -19%) with 5 mg]. Throughout the trial the value of P1NP in the 2.5 and 5 mg dose groups was significantly lower than the placebo group (p<0.0001). In the 1 mg dose group, P1NP values were lower than the placebo group, except at the two year time point.
- Comparison between zoledronate groups suggests the 2.5 mg zoledronate group produced changes in BMD and bone turnover markers which fell within +/- 1.5%, and +/- 15% of those observed in the 5 mg group, respectively. Contrarily, the 1-mg dose was not equivalent to the 5-mg dose for any of the BMD or turnover endpoints.
- In the zoledronate group, 1 participant developed iritis (with 5 mg), and 5 developed fractures (1 with 1 mg dose, 2 with 2.5 mg dose, 2 with 5 mg dose). In the placebo group, 3 participants developed fractures. No patient developed osteonecrosis of the jaw or suffered an atypical femoral fracture.
最も覚えておくべきことは？
A single administration of 1 mg and 2.5 mg doses of intravenous zoledronate produced antiresorptive effects for at least two years, although the 1 mg antiresorptive effects appear to slow after 12 months. At 2 years post-intervention, the change in bone mineral density (BMD) and bone turnover markers in the 2.5 mg dose group were similar to effects induced by 5 mg.
それが私の患者ケアにどのように影響するか？
Results from this study suggest that a single administration of 2.5 mg zoledronate may be equally effective in increasing total bone mineral density and decreasing bone turnover markers as a 5 mg dose. Caution must be exercised when considering comparative efficacy between these doses however; the study compared doses to placebo and not direct comparisons between doses. Direct comparisons are thus needed in future trials.
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