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Clinical Trials/NCT00091832
NCT00091832CompletedPhase 2

A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.

Amgen0 sites255 target enrollmentStarted: September 2004Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Amgen
Enrollment
255
Primary Endpoint
Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)

Study Overview

Brief Summary

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically or cytologically confirmed breast adenocarcinoma
  • At least one bone metastasis

Exclusion Criteria

  • Not provided

Arms & Interventions

Denosumab 60 mg every 12 weeks

Experimental

Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.

Intervention: Denosumab (Biological)

Denosumab 120 mg every 4 weeks

Experimental

Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Intervention: Denosumab (Biological)

Denosumab 180 mg every 4 weeks

Experimental

Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Intervention: Denosumab (Biological)

IV bisphosphonates every 4 weeks

Active Comparator

Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks.

Intervention: IV Bisphosphonates (Drug)

Denosumab 180 mg every 12 weeks

Experimental

Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.

Intervention: Denosumab (Biological)

Denosumab 30 mg every 4 weeks

Experimental

Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Intervention: Denosumab (Biological)

Outcomes

Primary Outcomes

Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)

Time Frame: Baseline and Week 13

Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.

Secondary Outcomes

  • Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13(Baseline and Week 13)
  • Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)(Baseline and Week 25)
  • Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25(Baseline and Week 25)
  • Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline(Baseline to Week 57)
  • Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)(Baseline and week 13)
  • Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)(Baseline and Week 25)
  • Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)(Baseline and Week 13)
  • Percent Change From Baseline to Week 25 in P1NP(Baseline and Week 25)
  • Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)(Baseline and Week 13)
  • Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)(Baseline and Week 25)
  • Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)(Baseline and Week 13)
  • Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)(Baseline and Week 25)
  • Percent Change From Baseline to Week 13 in Osteocalcin(Baseline and Week 13)
  • Percent Change From Baseline to Week 25 in Osteocalcin(Baseline and Week 25)
  • Time to First Skeletal Related Event(Day 1 to Week 25)
  • Number of Participants With Skeletal Related Events(From Day 1 to Week 25)
  • Number of Participants With Hypercalcemia(Day 1 to Week 57)

Investigators

Sponsor
Amgen
Sponsor Class
Industry
Responsible Party
Sponsor

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