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A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis

NCT03432533 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2020-11-23

Study results available
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Summary

To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)

Conditions

  • Post-Menopausal Osteoporosis

Interventions

DRUG

romosozumab HCP administration with PFS

210 mg romosozumab SC QM by HCP administration with 2 PFS

DEVICE

romosozumab self-administration with AI/Pen

210 mg romosozumab SC QM by self-administration with 2 AI/Pens

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2019-04-11
Completion
2020-01-08
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Poland
  • United Kingdom

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 NCT03432533 on ClinicalTrials.gov