Immune checkpoint inhibitors and fracture risk: a systematic literature review and pooled and meta-analysis of randomized controlled trials
Pooled result · Any fracture (pooled analysis)Result — go to the resultOdds ratio 1.10 95% CI 0.80–1.50Authors' conclusion
There was no statistically significant difference in reported fractures between ICI and non-ICI treatment groups. However, few studies reported fracture outcomes and observation periods for these studies were short.
Study context
- Population
- Individuals with solid malignancies in phase II and III ICI randomized controlled trials (RCTs) reporting fractures (PubMed and Embase, inception to September 25, 2024)
- Participants
- 23,404 individuals35 RCTs
- Comparison
- ICI therapy vs non-ICI treatment
- Outcome
- Fracture risk (any, osteoporotic, pathologic) with ICI vs non-ICI
Methodological detailsrandom-effects meta-analysis, multivariate meta-regression, phase II and III RCTs, Subgroup analyses: studies without an active comparator; and without an active comparator with ≥ 6 months of ICI treatment
- Random-effects meta-analysis
- Multivariate meta-regression
- Phase II and III RCTs
- Subgroup analyses: studies without an active comparator; and without an active comparator with ≥ 6 months of ICI treatment
Pooled result
Any fracture (pooled analysis)
Odds ratio
1.10
95% CI 0.80–1.50
P = 0.54
Events by group
ICI
91
events
Controls
70
events
ICIvs Controls
OR 1.10 (95% CI 0.80–1.50); P = 0.54
As reported in the abstract
Further pooled results
Events
| Outcome | ICI | Controls | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Pathologic fracture (pooled analysis) | 5 | 5 | 0.84 (0.26–2.73) | P = 0.79 | |
| 0.20.5125Odds ratio (log scale) |
Events
| Outcome | ICI | Controls | Estimate | P value |
|---|---|---|---|---|
| Osteoporotic fracture (pooled analysis) | 66 | 49 | 1.14 (95% CI 0.78–1.64) | P = 0.48 |
Meta-analysis, meta-regression and heterogeneity
- Statistical heterogeneity non-significant (I2)
- 0.0%
- Meta-analysis similarly showed no statistically significant differences
- Meta-regression identified no variables associated with increased fracture risk
Original publication
Immune checkpoint inhibitors and fracture risk: a systematic literature review and pooled and meta-analysis of randomized controlled trials. J Bone Miner Res. Published 25 April 2026. doi:10.
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