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Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study (EDGE)

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: NCT02139007
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Kenneth Saag, MD, MSc, University of Alabama at Birmingham

Study Description
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Brief Summary:
This is a pilot study evaluating the recruitment strategies for sites and patients, data collection instruments, follow-up procedures, administrative processes, and the proposed management strategy for the future large scale national trial.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Alendronate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
Actual Study Start Date : June 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Continuation Arm
Alendronate continuation arm
 Drug: Alendronate
Active Comparator: Discontinuation Arm
Alendronate discontinuation arm
 Drug: Alendronate


Outcome Measures
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Primary Outcome Measures :
  1. All Study Sites--Length of Contracting Procedures [ Time Frame: Length of time Between Clinical Site Recruitment and Contract Execution ]
    Mean time Between Clinical Site Recruitment and Contract Execution

  2. All Study Sites--Length of Time to Site IRB Approval [ Time Frame: Length of time to site IRB approval ]
    Mean time to gain site IRB approval

  3. All Study Sites-Length of Time to 1st Participant Enrolled [ Time Frame: Length of time t for sites to recruit/enroll 1st participant ]
    Mean time from study initiation to 1st participant enrolled.


Secondary Outcome Measures :
  1. Clinical Fracture Rate [ Time Frame: Baseline to 6 months following enrollment ]
    Patient reported fracture rate at 6 months following enrollment via survey.

  2. Atypical Femoral Fracture [ Time Frame: Baseline to 6 months following enrollment ]
    Patient reported fracture rate at 6 months after enrollment via follow-up survey

  3. Osteonecrosis of the Jaw [ Time Frame: Baseline to 6 months following enrollment ]
    Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.Females 65+

2.3+ years of alendronate (Fosamax/Binosto) use

3. Valid social security number

Exclusion Criteria:

  1. History of any other metabolic bone condition, such as Paget Disease of Bone
  2. Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.
  3. Has significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years)?
  4. HIV positive
  5. Involved in a conflicting (investigational drug) clinical trial
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): NCT02139007


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Kenneth G Saag, MD University of Alabama at Birmingham
More Information
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Responsible Party: Kenneth Saag, MD, MSc, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02139007    
Other Study ID Numbers: F120404006
First Posted: May 15, 2014    Key Record Dates
Results First Posted: May 12, 2017
Last Update Posted: May 12, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs