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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Radius Health, Inc.
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.
ClinicalTrials.gov Identifier:
NCT01657162
First received: July 31, 2012
Last updated: June 25, 2014
Last verified: June 2014
  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 ] [ 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: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alendronate
Alendronate
Drug: Alendronate
Bisphosphonate

  Eligibility

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 Were withdrawn from Study BA058-05-003 for any reason.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

Contacts
Contact: Radius Health, Inc. (617) 551-4700 info@radiuspharm.com

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

No publications provided

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: June 25, 2014
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.:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014