NCT01920568

A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors

DCA114273: A Study Comparing Denosumab With Zoledronic Acid in Subjects of Asian Ancestry With Bone Metastases From Solid Tumors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 487 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fractures, Bone

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-02-01
• Completion: 2016-04-01
• First posted: 2013-08-12
• Last updated: 2017-01-16
• Results posted: 2016-08-25

Locations

25 sites across 3 countries: China, Singapore, Taiwan