Ann Oncol

Fracture risk drops with bisphosphonate add-on to ADT in metastatic prostate cancer

August 5, 2025

Study details: This secondary analysis of the STAMPEDE phase 3 trials evaluated fracture-related hospitalizations (FRH) in men with newly diagnosed high-risk non-metastatic (M0) or metastatic (M1) hormone-sensitive prostate cancer receiving androgen deprivation therapy (ADT). Patients were randomized to ADT alone or ADT plus zoledronic acid, docetaxel, or both. Linked hospital data from England were used to identify FRH via ICD-10 and OPCS codes, with flexible parametric competing risks models estimating 5- and 10-year cumulative incidence and sub-distribution hazard ratios (SDHR).

Results: Among 2,042 eligible patients (M0: n=734; M1: n=1,308), the 5-year cumulative incidence of fracture was 11% and 23% for M0 and M1, respectively. In M0 patients, 10-year incidence reached 26% (95% confidence interval [CI], 20-33%). Zoledronic acid significantly reduced fracture risk in M1 patients by 27% (95% CI, 0.55–0.97; p=0.015), but not in M0 patients. Docetaxel showed no significant impact on fracture risk in either group (M0: p=0.570; M1: p=0.264).

Clinical impact: These findings support the use of bone-protective agents like zoledronic acid in men with metastatic prostate cancer undergoing ADT. Fracture prevention strategies should be prioritized, especially in M1 patients, to reduce morbidity and healthcare burden.

Source:

Jones C, et al; STAMPEDE Trial Investigators. (2025, July 16). Ann Oncol. Fracture-related hospitalisations in newly diagnosed high-risk localised or metastatic hormone-sensitive prostate cancer: secondary analysis of the STAMPEDE phase 3 trials of docetaxel and zoledronic acid using healthcare systems data. https://pubmed.ncbi.nlm.nih.gov/40680994/