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

NCT01920568 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 487

Last updated 2017-01-16

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-02-28
Completion
2016-04-30

Countries

  • China
  • Singapore
  • Taiwan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01920568 on ClinicalTrials.gov