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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Radius Health, Inc. Identifier:
First received: July 31, 2012
Last updated: January 14, 2015
Last verified: January 2015
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 ] [ Designated as safety issue: Yes ]
    Incidence and severity of Adverse Events, Fractures, and Changes in Clinical Laboratory Values

Secondary Outcome Measures:
  • Vertebral Fracture Incidence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Non-vertebral Fracture Incidence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Drug: Alendronate


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

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 Were withdrawn from Study BA058-05-003 for any reason.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 identifier: NCT01657162

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

Responsible Party: Radius Health, Inc. 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
Health Authority: Argentina: Ministry of Health
Brazil: Ministry of Health
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Hong Kong: Department of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
United States: Food and Drug Administration

Keywords provided by Radius Health, Inc.:
bone loss

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on January 14, 2017