Concerns about reporting in trials of strontium ranelate
| Undetected adverse events | A significant increase in myocardial infarction risk in TROPOS at 5 years was not detected/reported, despite cardiac safety of strontium being specifically considered by the regulator |
| Unreported adverse events | Significant increases in venous thromboembolism and pulmonary embolism with strontium reported in regulatory documents but not primary publications, subsequent publications or review publications |
| Difference in primary analyses | The primary result for TROPOS in the regulatory document was from an unadjusted analysis and was statistically non-significant. The result in the primary publication was from an adjusted analysis and was statistically significant |
| Misrepresented study design | SOTI described as 3 years study in primary publication instead of 5 years study with main analysis at 3 years |
| Unpublished clinical trials | Prevos 005, ‘CL3-017’ and ‘CL3-028’ are unpublished. (approximately 3.5% of all participants in strontium clinical trials programme) |
| Discrepant data | Unexplained differences between results in regulatory documents and primary publications |