Overview

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

Summary

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
Arm
(Experimental)
Alendronate
alendronate
Bisphosphonate

Primary Outcomes

Measure
Safety
time frame: 6 months

Secondary Outcomes

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 Were withdrawn from Study BA058-05-003 for any reason. 2.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