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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: N/A
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
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Alendronate
Alendronate
 Drug: Alendronate
Bisphosphonate


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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


Locations
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United States, Colorado
Lakewood, Colorado, United States
United States, Florida
NMiami, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Maryland
Bethesda, Maryland, United States
Argentina
Buenos Aires, Argentina
Brazil
Brasilia, Brazil
Curitiba, Brazil
Rio de Janeiro, Brazil
Sao Paolo, Brazil
Vitoria, Brazil
Czech Republic
Brno, Czech Republic
Pardubice, Czech Republic
Prague, Czech Republic
Denmark
Aalborg, Denmark
Ballerup, Denmark
Vejie, Denmark
Estonia
Tallinn, Estonia
Tartu, Estonia
Hong Kong
Hong Kong, Hong Kong
Lithuania
Vilnius, Lithuania
Poland
Bialystok, Poland
Katowice, Poland
Kielce, Poland
Lodz, Poland
Warsaw, Poland
Zgierz, Poland
Romania
Bucharest, Romania
Sponsors and Collaborators
Radius Health, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT01657162    
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:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs