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Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

NCT01343004 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2463

Last updated 2017-03-01

Study results available
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Summary

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

Conditions

Interventions

DRUG

Placebo

Placebo 0 mcg subcutaneous daily

DRUG

BA058 80 mcg

BA058 80 mcg subcutaneous daily

DRUG

teriparatide

teriparatide 20 mcg subcutaneous daily

Sponsors & Collaborators

  • Radius Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Radius Health, Inc. · Radius Health, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States
  • Argentina
  • Brazil
  • Czechia
  • Denmark
  • Estonia
  • Hong Kong
  • Lithuania
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01343004 on ClinicalTrials.gov