PMID- 36703260
OWN - NLM
STAT- MEDLINE
DCOM- 20230503
LR  - 20230504
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 32
IP  - 6
DP  - 2023 Jun
TI  - Evaluation of the efficacy and safety of romosozumab (evenity) for the treatment 
      of osteoporotic vertebral compression fracture in postmenopausal women: A 
      systematic review and meta-analysis of randomized controlled trials (CDM-J).
PG  - 671-684
LID - 10.1002/pds.5594 [doi]
AB  - PURPOSE: Osteoporotic vertebral compression fracture (OVCF) is a common fragile 
      fracture resulting from osteoporosis. We compared the efficacy and safety of 
      romosozumab and commonly used osteoporosis drug treatments for the treatment of 
      OVCF in postmenopausal women. METHODS: Through searching and screening five 
      databases, we included randomized controlled trials (RCTs) published through June 
      18, 2021 comparing different treatments. Following the Preferred Reporting Items 
      for Systematic Reviews statement, the main objective was to evaluate the mean 
      difference and risk ratio of the treatment effect. The primary measures of 
      romosozumab efficacy used in this study were vertebral, non-vertebral, and 
      clinical fracture events, and secondary outcomes were bone mineral density (BMD) 
      changes at the lumbar spine, total hip, and femoral neck and the incidence of 
      adverse events (AEs), RESULTS: Nine RCTs including 12 796 participants were 
      included in the analysis, and romosozumab was compared with placebo, alendronate, 
      and teriparatide in the treatment of osteoporosis in postmenopausal women. The 
      incidence of fractures, low BMD, and AEs was analyzed. Compared with the 
      controls, three doses of romosozumab were linked to evident advantages in the 
      treatment of low BMD and fractures but associated with increased hypersensitivity 
      and injection site reaction risks. Furthermore, fewer AEs were observed in the 
      romosozumab arms (210 mg: risk ratio = 0.96, 95% confidence interval = 0.93-0.99; 
      140 mg: risk ratio = 0.28, 95% confidence interval = 0.08-0.98) than in the 
      alendronate and placebo arms. CONCLUSIONS: Our meta-analysis revealed the evident 
      advantages of romosozumab in the treatment of osteoporosis and low BMD in 
      postmenopausal women and increased risks of hypersensitivity and injection site 
      reactions.
CI  - (c) 2023 John Wiley & Sons Ltd.
FAU - Huang, Wenbo
AU  - Huang W
AUID- ORCID: 0000-0002-6770-9829
AD  - Clinical Translational Science, Juntendo University Graduate School of Medicine, 
      Tokyo, Japan.
FAU - Nagao, Masashi
AU  - Nagao M
AUID- ORCID: 0000-0002-8909-4650
AD  - Clinical Translational Science, Juntendo University Graduate School of Medicine, 
      Tokyo, Japan.
AD  - Medical Technology Innovation Center, Juntendo University, Tokyo, Japan.
AD  - Department of Orthopaedic Surgery, Juntendo University Faculty of Medicine, 
      Tokyo, Japan.
FAU - Yonemoto, Naohiro
AU  - Yonemoto N
AD  - Department of Public Health, Juntendo University Graduate School of Medicine, 
      Tokyo, Japan.
FAU - Guo, Sen
AU  - Guo S
AUID- ORCID: 0000-0003-2740-0744
AD  - Department of Data Science, Juntendo University Graduate School of Medicine, 
      Tokyo, Japan.
FAU - Tanigawa, Takeshi
AU  - Tanigawa T
AD  - Department of Public Health, Juntendo University Graduate School of Medicine, 
      Tokyo, Japan.
FAU - Nishizaki, Yuji
AU  - Nishizaki Y
AD  - Clinical Translational Science, Juntendo University Graduate School of Medicine, 
      Tokyo, Japan.
AD  - Medical Technology Innovation Center, Juntendo University, Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20230215
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 3VHF2ZD92J (romosozumab)
RN  - 0 (Bone Density Conservation Agents)
RN  - X1J18R4W8P (Alendronate)
SB  - IM
MH  - Female
MH  - Humans
MH  - *Bone Density Conservation Agents
MH  - Alendronate/therapeutic use
MH  - *Osteoporosis, Postmenopausal/drug therapy
MH  - *Fractures, Compression/chemically induced/drug therapy
MH  - Postmenopause
MH  - Randomized Controlled Trials as Topic
MH  - *Osteoporosis/chemically induced
MH  - Bone Density
OTO - NOTNLM
OT  - meta-analysis
OT  - osteoporosis
OT  - postmenopausal
OT  - romosozumab
EDAT- 2023/01/27 06:00
MHDA- 2023/05/03 06:42
CRDT- 2023/01/26 23:53
PHST- 2023/01/20 00:00 [revised]
PHST- 2022/12/08 00:00 [received]
PHST- 2023/01/23 00:00 [accepted]
PHST- 2023/05/03 06:42 [medline]
PHST- 2023/01/27 06:00 [pubmed]
PHST- 2023/01/26 23:53 [entrez]
AID - 10.1002/pds.5594 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2023 Jun;32(6):671-684. doi: 10.1002/pds.5594. Epub 
      2023 Feb 15.