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A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

NCT02157948 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2017-08-16

Study results available
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Summary

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Denosumab (CP2)

Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.

DRUG

Denosumab (CP4)

Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Canada
  • Denmark
  • Poland

Study Locations

More Related Trials

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 NCT02157948 on ClinicalTrials.gov