This trial is active, not recruiting.

Condition postmenopausal osteoporosis
Treatment alendronate
Phase phase 3
Sponsor Radius Health, Inc.
Start date October 2012
End date October 2016
Trial size 1200 participants
Trial identifier NCT01657162, ACTIVExtend Trial, BA058-05-005


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

time frame: 6 months

Secondary Outcomes

Vertebral Fracture Incidence
time frame: 6 months
Non-vertebral Fracture Incidence
time frame: 6 months

Eligibility Criteria

Female participants of any age.

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 Were withdrawn from Study BA058-05-003 for any reason. 2.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.

Additional Information

Official title An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 (Abaloparatide) or Placebo Treatment in Protocol BA058-05-003
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Radius Health, Inc..