Resuming Romosozumab After Acute Fracture
Continue romosozumab treatment immediately after an acute fracture without interruption. The available evidence supports maintaining romosozumab therapy through the acute fracture period rather than stopping it.
Evidence Supporting Continuation
Post-fracture continuation of romosozumab demonstrates efficacy and safety without fracture-related complications. A post-hoc analysis of the FRAME and ARCH trials specifically examined patients who experienced fractures while on romosozumab treatment 1. Key findings include:
- Patients who experienced on-study fractures by Month 12 and continued romosozumab had numerically lower rates of recurrent fractures compared to those on placebo or alendronate 1
- In FRAME, patients with nonvertebral fractures who continued romosozumab had recurrent fracture rates of 3.6% versus 9.2% in the placebo group 1
- In ARCH, patients with vertebral fractures who continued romosozumab had recurrent vertebral fracture rates of 9.0% versus 15.0% in the alendronate group 1
- No fracture-related complications were reported in romosozumab-treated patients who experienced on-study fractures 1
- Bone mineral density gains remained numerically greater with continued romosozumab treatment post-fracture 1
Clinical Trial Context
A dedicated phase-2 trial evaluated romosozumab specifically for fresh tibial diaphyseal fractures, administering the first dose on postoperative day 1 2. While romosozumab did not accelerate fracture healing in this surgical population, the safety profile was comparable to placebo, demonstrating that romosozumab administration in the immediate post-fracture period is safe 2.
Treatment Sequencing Considerations
After completing the 12-month romosozumab course, transition to an antiresorptive agent is essential to maintain bone density gains 3, 4. The American College of Physicians provides moderate-certainty evidence that romosozumab followed by alendronate reduces fractures without higher risk for serious harms 3.
Important Caveats
- The primary concern with romosozumab is cardiovascular risk, not fracture-related complications 3. Romosozumab should not be initiated in patients with myocardial infarction or stroke within the preceding 12 months 3
- Romosozumab is limited to 12 monthly doses total because the anabolic effect wanes after this period 3
- If a patient was previously on denosumab and experienced discontinuation, romosozumab alone may not prevent rebound vertebral fractures; reinitiation of denosumab should be considered instead 5