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Postmenopausal Osteoporosis | Twenty Four Month Extension Study of BA058-05-003

Postmenopausal Osteoporosis research study

What is the primary objective of this study?

The purpose of this study is to provide 24 months of standard of care data on subjects previously enrolled in study BA058-05-003.

Who is eligible to participate?

Inclusion Criteria: 1. The subject was enrolled, randomized to either the BA058 (abaloparatide) or placebo arm, and successfully completed Study BA058-05-003. Exclusion Criteria: 1. Were withdrawn from Study BA058-05-003 for any reason. 2. Experienced a treatment-related SAE during Study BA058-05-003.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postmenopausal Osteoporosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AlendronateBisphosphonate

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

AlendronateAlendronate

Study Status

Completed

Start Date: October 2012

Completed Date: October 2016

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Safety

Secondary Outcome: Vertebral Fracture Incidence

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Radius Health, Inc.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01657162

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