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?
1. The subject was enrolled, randomized to either the BA058 (abaloparatide) or placebo arm,
and successfully completed Study BA058-05-003.
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 Were withdrawn from Study BA058-05-003 for any reason.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?
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.
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.
Start Date: October 2012
Completed Date: October 2016
Phase: Phase 3
Primary Outcome: Safety
Secondary Outcome: Vertebral Fracture Incidence
Study sponsors, principal investigator, and references
Lead Sponsor: Radius Health, Inc.