A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors
Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, double-dummy study designed to provide bridging data in
an Asian population to Amgen's studies of denosumab in subjects with bone metastases from
solid tumors. The study is designed to provide data to a large global dataset of phase-III
studies including breast cancer, prostate cancer, and all solid tumors, plus multiple
myeloma, to support the regulatory approval for marketing and patient access to denosumab for
the prevention of SREs in Chinese subjects with bone metastases from solid tumors. The
primary objective of this study is to evaluate and compare the percent change from baseline
to Week 13 in the bone marker urinary amino-terminal cross-linking telopeptide of type I
collagen (uNTx) corrected for urine creatinine (uNTx/uCr) in subjects treated with denosumab
to those treated with zoledronic acid. The study is designed to test the superiority of
denosumab over zoledronic acid.
Phase:
Phase 3
Details
Lead Sponsor:
GlaxoSmithKline
Collaborator:
Amgen
Treatments:
Calcium Denosumab Diphosphonates Vitamin D Vitamins Zoledronic Acid