Objective: To systematically evaluate the efficacy and safety of zoledronic acid in the treatment of bone metabolic diseases in children. Methods: PubMed

the Cochrane Library

EMBase

CNKI

VIP

Wanfang database

Clinical Trials

Cochrane Central Registry of Controlled Trials

and the International Clinical Trials Registry Platform were retrieved

the retrieval time was from the establishment of the database to Dec. 2021. Randomized controlled trials (RCT)

case-control studies

case series studies and case reports related to zoledronic acid in the treatment of bone metabolic disorders were collected. Quality assessments for RCT

case series studies and case reports were performed by using the Cochrane Risk of Bias Assessment and the Australian JBI Quality Assessment

respectively. Meta-analysis was conducted by using Rev Man 5.3 software for RCT

while descriptive analysis was employed for other study types. Results: A total of 16 studies were enrolled

including 4 RCT

2 case series studies

and 10 case reports. No cohort studies or case-control studies specifically related to children were identified. Meta-analysis results indicated a statistically significant difference in the lumbar spine bone density score of efficacy outcome measure between the zoledronic acid group and the control group (MD=0.45

95% CI from 0.06 to 0.84

P=0.02). Regarding safety outcomes

no statistically significant differences were observed between the zoledronic acid group and the placebo group (RR=1.14

95% CI from 0.82 to 1.60

P=0.44) or other bisphosphonates group (pamidronate

alendronate

RR=1.33

95% CI from 0.53 to 3.35

P=0.55). The incidence of adverse events in the nervous system

digestive system

general condition

administration site and skeleton and connective tissue was comparable between the experimental group and the control group. Similarly

the incidence of adverse events related to nervous system

digestive system

skeleton and connective tissue

and fractures was comparable between experimental group and other bisphosphonates group. There was no significant difference in the incidence of severe adverse events between the experimental group and the control group (RR=2.59

95% CI from 0.54 to 12.50

P=0.24). Conclusion: Zoledronic acid demonstrates effective efficacy for bone metabolic disorders in children. The overall incidences of adverse events and severe adverse events are comparable between zoledronic acid and placebo and other bisphosphonates

especially in terms of adverse events related to the nervous system

digestive system

and skeletonl and connective tissue. [Keywords] zoledronic acid; children; bone metabolic disorders; safety; efficacy; systematic review