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)?
Sì = 1
Incerto = 0,5
Non rilevante = 0
No = 0
La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.
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
L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.
Perché questo studio era necessario ora?
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 la domanda di ricerca principale?
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)
Che cosa devo ricordare di più?
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.
Come influenzerà l'assistenza ai miei pazienti?
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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