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A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

NCT02016716 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2018-11-08

Study results available
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Summary

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Romosozumab 90 mg/mL

Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).

DRUG

Placebo 90 mg/mL

Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.

DRUG

Romosozumab 70 mg/mL

Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.

DRUG

Placebo 70 mg/mL

Placebo administered as 3 SC injections with the 1.0 mL glass PFS.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-03
Primary Completion
2014-09-08
Completion
2014-12-08

Countries

  • United States
  • Czechia
  • Poland

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 NCT02016716 on ClinicalTrials.gov