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Similar Relationship Between the Time Course of Bone Mineral Density Improvement and Vertebral Fracture Risk Reduction With Denosumab Treatment in Postmenopausal Osteoporosis and Prostate Cancer Patients on Androgen Deprivation Therapy
Author(s) -
Pérez Ruixo Juan Jose,
Zheng Jenny,
Mandema Jaap W.
Publication year - 2014
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.228
Subject(s) - denosumab , medicine , prostate cancer , osteoporosis , bone mineral , androgen deprivation therapy , urology , oncology , cancer
Denosumab has received approval in many countries and indications include treating women with postmenopausal osteoporosis (PMO) at increased or high risk for fracture and men at high risk for fracture receiving androgen deprivation therapy (ADT) for non‐metastatic prostate cancer. Increases in total hip bone mineral density (BMD) with denosumab explained a large percentage of new vertebral fracture risk reduction in women with PMO; however, this effect has not been studied in men with prostate cancer receiving ADT. We compared the relationship between the time course of BMD changes and new vertebral fracture risk reduction with denosumab in women with PMO and men with prostate cancer. After adjusting for different baseline hazards, a significant and similar relationship between time course of total hip and lumbar spine BMD changes and new vertebral fracture risk was observed in both patient populations. Time course of total hip BMD changes with denosumab was the best predictor for changes in fracture risk and explained 88% of the new vertebral fracture risk reduction in women with PMO and 91% in men with prostate cancer. Therefore, total hip BMD is a useful surrogate to measure the clinical impact of denosumab on fracture risk reduction in both patient populations.