Smartphone-based patient-reported outcome of acute phase reaction after zoledronic acid infusion and prediction algorithm: a multicenter, prospective cohort study
Authors' conclusion
Smartphone-based ePRO effectively captured APR severity following ZOL. A simple clinical algorithm using age, sex, and day-1 symptoms accurately identified individuals at high risk for severe APR
Study context
- Population
- Adults aged ≥ 19 years receiving a single 5-mg ZOL infusion for osteoporosis (mean age 70.6 years; 83.7% women)
- Participants
- 685 adults
- Exposure
- Severe acute phase reaction (APR) vs Mild-to-moderate APR
- Severe APRn = 118
- Outcome
- Severe APR after ZOL infusion and its prediction by age, sex and day-1 symptoms
- Follow-up
- 4 days
Methodological detailsmulticentre, observational, smartphone-based electronic patient-reported outcome (ePRO)
- Multicentre
- Observational
- Smartphone-based ePRO
Main finding
As reported in the abstract
APR after ZOL infusion
Any APR
222
32.4%
Severe APR
118
17.2%
Discrimination of compact model (age, sex, number of day-1 core symptoms) for severe APR, AUROC
0.81
Observational data: associations, not effects.
Further findings
Time course and predictors of APR
- APR scores peaked on day 2 and declined by day 4
- Severe APR: earlier onset, longer duration, greater symptom burden than mild-to-moderate APR
- Younger age and female sex associated with severe APR
- Core day-1 predictors: myalgia, arthralgia, chills, headache, back pain
Original publication
Smartphone-based patient-reported outcome of acute phase reaction after zoledronic acid infusion and prediction algorithm: a multicenter, prospective cohort study. Osteoporos Int. Published 3 August 2026. doi:10.
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