Effects of 2.5mg zoledronate are long-lasting and similar to 5mg dose in osteopenic women .
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by one or more authors of the
original publication.
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)?
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
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
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?
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.
Qual era a principal questão de investigação?
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?
- 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.
De que é que me devo lembrar mais?
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.
Como é que isto afectará o tratamento dos meus doentes?
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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