Effects of ch-OSA and Ca/Vit D3 administration in osteopenic women .
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)?
Sim = 1
Incerto = 0,5
Não relevante = 0
Não = 0
A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.
4/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/5
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.
Porque é que este estudo era necessário agora?
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.
Qual era a principal questão de investigação?
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?
- 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)
De que é que me devo lembrar mais?
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.
Como é que isto afectará o tratamento dos meus doentes?
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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