Body weight predicts denosumab pharmacodynamic duration: a real-world longitudinal cohort study
Authors' conclusion
Body weight is an independent determinant of model-predicted denosumab pharmacodynamic duration.
Study context
- Population
- Adults with osteoporosis treated with denosumab 60 mg SC every 6 months, 2020–2025
- Participants
- 2,123 adults
- Exposure
- Predicted CTX/P1NP threshold-crossing time after denosumab injection by body weight
- Outcome
- Time from injection until operational thresholds crossed (CTX > 0.28 ng/mL; P1NP > 35 ng/mL), by body weight
Methodological detailslongitudinal, real-world, generalized additive models and random forests, 4257 CTX and 4477 P1NP measurements
- Longitudinal
- Real-world
- Generalized additive models and random forests
- 4257 CTX and 4477 P1NP measurements
Main finding
As reported in the abstract
CTX threshold-crossing time (GAM-predicted)
Predicted CTX threshold-crossing time at 40 kg
262 days
8.7 months; 95% CI: 236–296
Predicted CTX threshold-crossing time at 80 kg
196 days
6.5 months; 95% CI: 180–238
Slope
- 1.60 days/kg
95% CI - 2.03 to - 1.17
Random forest vs GAM agreement for CTX (Pearson r)
0.917
Observational data: associations, not effects.
Further findings
P1NP threshold-crossing time
- Inverted U-shaped pattern, longest predicted interval at intermediate body weights; P1NP less informative for interval estimation
Sensitivity analyses (alternative thresholds, one observation per patient per cycle, parathyroid hormone (PTH) adjustment)
- All preserved the weight-stratified gradient
Original publication
Body weight predicts denosumab pharmacodynamic duration: a real-world longitudinal cohort study. Osteoporos Int. Published 31 August 2026. doi:10.
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