Denosumab in osteoporosis-related fractures. A critical appraisal of the FREEDOM trial
Denosumab has shown efficacy vs placebo in the reduction of morphometric vertebral fractures, an endpoint of dubious clinical relevance. Data on prevention of hip fractures are inconclusive. Safety data published do not concur with the drug information available from regulatory agencies. Due to the exclusion criteria in the trial, the results are not applicable to women previously treated with bisphosphonates. Given the high risk of bias of the FREEDOM trial, the conclusions derived from this study should be considered with precaution. Furthermore, the serious irregularities found in the trial inspections raise concern on the veracity of the published data.
- Juan Erviti. Drug Prescribing Service. Navarre Regional Health Service. Spain
Entrevista a Juan Erviti, coordinador del Bit Navarra, sobre el ensayo clínico FREEDOM y el papel del denosumab (Prolia) en la osteoporosis