Twenty Four Month Extension Study of BA058-05-003

This study is currently recruiting participants.
Verified March 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: March 2, 2014
Last verified: March 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 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 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 Were withdrawn from Study BA058-05-003 for any reason.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
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
Study First Received: July 31, 2012
Last Updated: March 2, 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

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 April 16, 2014