Zoledronic acid increases BMD and prevents fracture risks in women with osteoporosis .
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)?
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.
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
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?
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.
Qual era la domanda di ricerca principale?
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?
- 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.
Che cosa devo ricordare di più?
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.
Come influenzerà l'assistenza ai miei pazienti?
The study recommends annual infusions of Zoledronic acid in treatment of women with osteoporosis. More blinded trials can further validate these findings.
DISCLAIMER
Il contenuto di questa pagina è solo a scopo informativo e non intende sostituire la consulenza, la diagnosi o il trattamento medico professionale. Se ha bisogno di cure mediche, si rivolga sempre al suo medico o al pronto soccorso più vicino. Le opinioni, le convinzioni e i punti di vista espressi dalle persone sui contenuti presenti in questa pagina non riflettono le opinioni, le convinzioni e i punti di vista di OrthoEvidence.
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