NCT01920568 - A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors | Biotech Hunter

Enrollment

487

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

April 30, 2016

Conditions

Fractures, Bone

Interventions

BIOLOGICAL

Denosumab 70 mg/mL

Denosumab will be given as a SC injection of 120 mg by administering a 1.7 mL volume in a single injection

DRUG

Zoledronic acid 4 mg

Zoledronic acid 4 mg (or equivalent clearance-adjusted dose in subjects with baseline creatinine clearance \<=60 ml/min) will be diluted in either 0.9% sodium chloride or 5% dextrose injection and administered IV.

DRUG

Placebo IV

The placebo will consist of 1.7 mL 0.9% w/v sodium chloride

DRUG

Placebo SC

The placebo will consist of either 0.9% w/v sodium chloride or 5% dextrose injection

DIETARY_SUPPLEMENT

Calcium supplement

Subjects are strongly recommended to take daily supplements of at least 500 mg calcium from the day of consent and until completion of the Week 73 follow-up visit.

DIETARY_SUPPLEMENT

Vitamin D supplement

Subjects are strongly recommended to take daily supplements of at least 400 IU of vitamin D from the day of consent and until completion of the Week 73 follow-up visit.

Trial Locations (25)

333

GSK Investigational Site, Taoyuan District

404

GSK Investigational Site, Taichung

100021

GSK Investigational Site, Beijing

100034

GSK Investigational Site, Beijing

100036

GSK Investigational Site, Beijing

100071

GSK Investigational Site, Beijing

119074

GSK Investigational Site, Singapore