Impact of Prior Radiation Therapy on Bone Mineral Density Change Over Time: Secondary Analysis of the Control Arm of a Phase III Randomized Trial
Abstract
PURPOSE/OBJECTIVE(S)
Retrospective studies have demonstrated that pelvic radiation therapy (RT) can lead to decreased bone mineral density (BMD) and increased risk of fracture. This is more relevant for men with prostate cancer (PCa) who often receive androgen deprivation therapy (ADT) in conjunction with RT. We performed a post-hoc secondary analysis of publicly available data of the control arm of a phase III randomized controlled study (NCT00089674) to determine if history of prior pelvic RT affects change in BMD over time in non-metastatic PCa patients treated with ADT.
MATERIALS/METHODS
In this study, PCa patients with age ≥70 years or 6 months) and age (<70 vs ≥70 years). BMD was measured at baseline, and at months 1, 3, 6, 12, 24, and 36 with blind reading by central reviewer. To model the effect of prior pelvic RT on dynamic change in BMD in the hip, lumbar spine, and femoral neck, we applied separate multivariate linear mixed effect models for each site. Age, ECOG performance score, history and number of prior fractures, smoking history, and years from initial cancer diagnosis were included as fixed covariates while patients were included as random intercepts.
RESULTS
Among 734 patients who were randomized to the control arm, 563 participants with baseline and at least one post baseline assessment of BMD were eligible for this analysis. Overall, 34.4% (n = 194) received prior RT. We did not find any significant association of dynamic change in BMD with receipt of…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 734 participants or records.
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