PMID- 23605142
OWN - NLM
STAT- MEDLINE
DCOM- 20141218
LR  - 20211021
IS  - 1437-7772 (Electronic)
IS  - 1341-9625 (Linking)
VI  - 19
IP  - 2
DP  - 2014 Apr
TI  - Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a 
      meta-analysis of seven randomized controlled trials.
PG  - 403-10
LID - 10.1007/s10147-013-0561-6 [doi]
AB  - AIMS: The aim of this study is to gain a better understanding of the overall 
      incidence and risk of osteonecrosis of the jaw (ONJ) in cancer patients receiving 
      denosumab. METHODS: We performed a meta-analysis of relevant randomized 
      controlled trials identified in Pubmed, Embase, and Cochrane databases. Abstracts 
      presented at the conferences were also searched. Overall incidence rates, 
      relative risk (RR), and 95 % confidence intervals (CI) were calculated employing 
      fixed- or random-effects models depending on the heterogeneity of the included 
      trials. RESULTS: A total of 8963 patients with a variety of solid tumors from 7 
      randomized controlled trials (RCTs) were included for the meta-analysis. The 
      overall incidence of ONJ in cancer patients receiving denosumab was 1.7 % [95 % 
      CI: 0.9-3.1 %]. Also, the use of denosumab was associated with significantly 
      increased risk of ONJ in comparison with bisphosphonates (BPs)/placebo treatment 
      (RR 1.61, 95 % CI: 1.05-2.48, P = 0.029). Subgroup analysis based on controlled 
      therapies demonstrated an increased risk of ONJ in denosumab therapy, when 
      compared with BPs (RR 1.48, 95 % CI: 0.96-2.29, P = 0.078) or placebo (RR 16.28, 
      95 % CI: 1.68-158.05, P = 0.017). Similar results were observed in prostate 
      cancer (RR 3.358, 95 % CI: 1.573-7.166, P = 0.002) while there was a 
      non-significantly increased risk of denosumab-related osteonecrosis of the jaw 
      (DONJ) in non-prostate cancers (RR 1.142, 95 % CI: 0.678-1.921, P = 0.618). 
      CONCLUSIONS: The use of denosumab is associated with an increased risk of 
      developing ONJ when compared with BP treatment or placebo, although the increased 
      risk was not statistically significant between denosumab and BP treatment. 
      Further studies are still needed to establish guidelines for the prevention and 
      effective treatment of ONJ.
FAU - Qi, Wei-Xiang
AU  - Qi WX
AD  - Department of Oncology, The Sixth People's Hospital, Shanghai Jiao Tong 
      University, No. 600, Yishan Road, Shanghai, 200233, China.
FAU - Tang, Li-Na
AU  - Tang LN
FAU - He, Ai-Na
AU  - He AN
FAU - Yao, Yang
AU  - Yao Y
FAU - Shen, Zan
AU  - Shen Z
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20130420
PL  - Japan
TA  - Int J Clin Oncol
JT  - International journal of clinical oncology
JID - 9616295
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (RANK Ligand)
RN  - 4EQZ6YO2HI (Denosumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/*adverse effects
MH  - Denosumab
MH  - Female
MH  - Humans
MH  - Jaw Diseases/*chemically induced
MH  - Male
MH  - Neoplasms/*drug therapy
MH  - Osteonecrosis/*chemically induced
MH  - Prostatic Neoplasms/drug therapy
MH  - Publication Bias
MH  - RANK Ligand/*antagonists & inhibitors
MH  - Randomized Controlled Trials as Topic
MH  - Risk
EDAT- 2013/04/23 06:00
MHDA- 2014/12/19 06:00
CRDT- 2013/04/23 06:00
PHST- 2013/01/31 00:00 [received]
PHST- 2013/04/09 00:00 [accepted]
PHST- 2013/04/23 06:00 [entrez]
PHST- 2013/04/23 06:00 [pubmed]
PHST- 2014/12/19 06:00 [medline]
AID - 10.1007/s10147-013-0561-6 [doi]
PST - ppublish
SO  - Int J Clin Oncol. 2014 Apr;19(2):403-10. doi: 10.1007/s10147-013-0561-6. Epub 
      2013 Apr 20.