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Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

NCT01657162 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1139

Last updated 2020-12-11

Study results available
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Summary

The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Alendronate

Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.

Sponsors & Collaborators

  • Radius Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce Mitlak · Radius Health, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-11-20
Primary Completion
2016-10-03
Completion
2016-10-03
FDA Drug
Yes

Countries

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

Study Locations

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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 NCT01657162 on ClinicalTrials.gov