METABOLIC DISORDERS
Choline-stabilized orthosilicic acid supplementation as an adjunct to Calcium/Vitamin D3 stimulates markers of bone formation in osteopenic females: A randomized, placebo-controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):103 BMC Musculoskelet Disord. 2008 Jun 11;9:85184 osteopenic (T-score spine < -1.5) caucasian women all received daily administration of 1000 mg Ca and 20 microg cholecalciferol (Vit D3). In addition, the women were randomized to receive either oral choline-stabilized orthosilicic acid (ch-OSA) or placebo treatment for 1 year. 136 women completed the study. At 1 year, the combined therapy of ch-OSA and Ca/Vit D3 demonstrated a potential beneficial effect on bone type I collagen formation (PINP) that was significant at 12 months for the 6 and 12 mg Si dose compared to Ca/Vit D3 treatment alone.
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
Randomização
4/4
Medidas de resultado
4/4
Inclusão/Exclusão
4/4
Descrição do tratamento
3/5
Estatística
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？
Recent research demonstrates a physiological role of silicon (Si) in the form of orthosilicic acid (OSA, Si(OH)4) in bone formation process. It has a particular scope in the treatment of osteoporosis, which is a leading cause of morbidity and mortality worldwide. The study was conducted as the effects of oral choline-stabilized orthosilicic acid (ch-OSA) on markers of bone turnover and bone mineral density (BMD) have been unknown.
主な研究課題は何ですか？
What are the effects of oral choline-stabilized orthosilicic acid (ch-OSA) on markers of bone turnover and bone mineral density (BMD), as evaluated over 12 months?
重要な知見は？
- Baseline bone markers levels were not significantly different between two groups (p>0.05)
- After 12 months, type I collagen formation (PINP) levels were significantly higher in intervention group compared to the placebo group (p<0.05)
- Lumbar spine and femur BMD remained unchanged after 12 months of ch-OSA administration
- A pattern for a dose dependent response was observed in the bone resorption marker, collagen type I C-terminal telopeptide (CTX-I)
- Post hoc analysis indicated that the BMD at the femoral neck exhibited a significant negative change from baseline T-score femur <-1 with the 6 mg dose compared to placebo (p<0.05)
最も覚えておくべきことは？
Combined therapy of ch-OSA and Ca/Vit D3 demonstrated a potentially beneficial effect on bone type I collagen formation (PINP), which was significant at 12 months for the 6 and 12 mg Si dose compared to Ca/Vit D3 treatment alone.
それが私の患者ケアにどのように影響するか？
There is potential for future use of combined therapy of ch-OSA and Ca/Vit D3 in osteoporosis with the observed beneficial effect on bone collagen compared to Ca/Vit D3 alone. However, further studies with larger population sizes should be conducted.
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