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Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

NCT01992159 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2019-03-25

Study results available
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Summary

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Conditions

  • Postmenopausal Osteoporosis (PMO)

Interventions

DRUG

Romosozumab

Administered by subcutaneous injection

DRUG

Placebo

Administered by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-10-12
Primary Completion
2014-10-09
Completion
2015-06-17

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT01992159 on ClinicalTrials.gov