Romosozumab followed by denosumab versus denosumab only: a post hoc analysis of FRAME and FRAME extension
Authors' conclusion
The sequence of Romo/DMAb resulted in greater BMD gains and higher probability of achieving T-scores > -2.5, significantly reduced new vertebral fracture incidence, and numerically lowered the incidence (not significant) of clinical, nonvertebral, and hip fractures versus DMAb only through 24 months.
Study context
- Population
- Women aged ≥55 years with TH or FN T-score −2.5 to −3.5 in FRAME and FRAME Extension
- Comparison
- Romosozumab followed by denosumab (DMAb) vs DMAb only for 24 months
Methodological detailspropensity score weighting, sensitivity analyses with PSW with multiple imputation (PSW-MI) and propensity score matching, E-values for unmeasured confounding
- Propensity score weighting
- Sensitivity analyses with PSW-MI and propensity score matching
- E-values for unmeasured confounding
Primary result
As reported in the abstract
Mean difference (LS bone mineral density (BMD))
9.3 %
P < 0.001
Romosozumab (Romo)/DMAb
Mean difference (TH BMD)
4.4 %
P < 0.001
Romo/DMAb
Mean difference (FN BMD)
4.1 %
P < 0.001
Romo/DMAb
Further findings
New vertebral fractures
OR 0.45 · P = 0.003
Probability of T-score > −2.5 at LS, baseline T-score −3.0 · month 24
Probability of T-score > −2.5 at TH, baseline T-score −3.0 · month 24
Clinical, nonvertebral and hip fractures
- Rates lower with Romo/DMAb (differences not significant)
Sensitivity analyses
- Similar BMD and fracture outcomes with PSW-MI and propensity score matching (PSM)
Original publication
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