Supportive Care in Cancer

, Volume 21, Issue 12, pp 3497–3507

Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid


    • Kantonsspital Graubünden
  • Jean-Jacques Body
    • Chu BrugmannUniversité Libre De Bruxelles
  • Blair Egerdie
    • Urology Associates/Urologic Medical Research
  • Alison Stopeck
    • Arizona Cancer CenterUniversity of Arizona
  • Janet E. Brown
    • Cancer Research UK Experimental Cancer Medicine Centres
  • Danail Damyanov
    • National Hospital for Treatment in Oncology
  • Lesley J. Fallowfield
    • Sussex Health Outcomes Research & Education in Cancer (SHORE-C)University of Sussex
  • Gavin Marx
    • Sydney Adventist HospitalUniversity of Sydney
  • Charles S. Cleeland
    • University of Texas MD Anderson Cancer Center
  • Donald L. Patrick
    • University of Washington
  • Felipe G. Palazzo
    • CAIPO
  • Yi Qian
    • Amgen Inc.
  • Ada Braun
    • Amgen Inc.
  • Karen Chung
    • Amgen Inc.
Original Article

DOI: 10.1007/s00520-013-1932-2

Cite this article as:
von Moos, R., Body, J., Egerdie, B. et al. Support Care Cancer (2013) 21: 3497. doi:10.1007/s00520-013-1932-2



This analysis evaluated patient-reported outcomes and analgesic use in patients with bone metastases from solid tumours across three comparative studies of denosumab and zoledronic acid.


Pooled data were analysed from three identically designed double-blind phase III studies comparing subcutaneous denosumab 120 mg with intravenous zoledronic acid 4 mg monthly in patients with bone metastases from breast cancer (n = 2,046), castration-resistant prostate cancer (n = 1,901) or other solid tumours (n = 1,597). Pain severity, pain interference, health-related quality of life and analgesic use were quantified.


At baseline, approximately half of patients had no/mild pain (53 % [1,386/2,620] denosumab; 50 % [1,297/2,578] zoledronic acid). Denosumab delayed onset of moderate/severe pain by 1.8 months (median, 6.5 vs 4.7 months; hazard ratio, 0.83; 95 % CI, 0.76–0.92; p < 0.001; 17 % risk reduction) and clinically meaningful increases in overall pain interference by 2.6 months (median, 10.3 vs 7.7 months; hazard ratio, 0.83; 95 % CI, 0.75–0.92; p < 0.001; 17 % risk reduction) compared with zoledronic acid. Strong opioid use and worsening of health-related quality of life were less common with denosumab.


Across three large studies of patients with advanced solid tumours and bone metastases, denosumab prevented progression of pain severity and pain interference more effectively than zoledronic acid.


DenosumabBone metastasesPainSolid tumoursZoledronic acid

Supplementary material

520_2013_1932_MOESM1_ESM.docx (52 kb)
ESM 1(DOCX 52.4 kb)
520_2013_1932_MOESM2_ESM.docx (80 kb)
ESM 2(DOCX 79 kb)

Copyright information

© Springer-Verlag Berlin Heidelberg 2013