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

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ClinicalTrials.gov Identifier: NCT01657162
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Alendronate Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2012
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Alendronate
Alendronate
Drug: Alendronate
Bisphosphonate



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


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


Information from the National Library of Medicine

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 Were withdrawn from Study BA058-05-003 for any reason.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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657162


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

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 ( Other Identifier: Radius Health, Inc. )
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

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
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs