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Twenty Four Month Extension Study of BA058-05-003 (ACTIVExtend)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Radius Health, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.
ClinicalTrials.gov Identifier:
NCT01657162
First received: July 31, 2012
Last updated: January 14, 2015
Last verified: January 2015
  Purpose
The purpose of this study is to provide 24 months of standard of care data on subjects previously enrolled in study BA058-05-003.

Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Alendronate
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Radius Health, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 6 months ]
    Incidence and severity of Adverse Events, Fractures, and Changes in Clinical Laboratory Values


Secondary Outcome Measures:
  • Vertebral Fracture Incidence [ Time Frame: 6 months ]
  • Non-vertebral Fracture Incidence [ Time Frame: 6 months ]

Estimated Enrollment: 1200
Study Start Date: October 2012
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alendronate
Alendronate
Drug: Alendronate
Bisphosphonate

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 Were withdrawn from Study BA058-05-003 for any reason.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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657162

  Show 27 Study Locations
Sponsors and Collaborators
Radius Health, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT01657162     History of Changes
Other Study ID Numbers: BA058-05-005  ACTIVExtend Trial 
Study First Received: July 31, 2012
Last Updated: January 14, 2015

Keywords provided by Radius Health, Inc.:
BA058
Abaloparatide-SC
abaloparatide
ACTIVExtend
osteoporosis
fracture
bone loss

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 24, 2017