Back to resultsEffectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study (EDGE)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Alendronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
1.Females 65+
2.3+ years of alendronate (Fosamax/Binosto) use
3. Valid social security number
Exclusion Criteria:
- History of any other metabolic bone condition, such as Paget Disease of Bone
- Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.
- 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)?
- HIV positive
- Involved in a conflicting (investigational drug) clinical trial
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Continuation Arm
Discontinuation Arm
Arm Description
Alendronate continuation arm
Alendronate discontinuation arm
Outcomes
Primary Outcome Measures
All Study Sites--Length of Contracting Procedures
Mean time Between Clinical Site Recruitment and Contract Execution
All Study Sites--Length of Time to Site IRB Approval
Mean time to gain site IRB approval
All Study Sites-Length of Time to 1st Participant Enrolled
Mean time from study initiation to 1st participant enrolled.
Secondary Outcome Measures
Clinical Fracture Rate
Patient reported fracture rate at 6 months following enrollment via survey.
Atypical Femoral Fracture
Patient reported fracture rate at 6 months after enrollment via follow-up survey
Osteonecrosis of the Jaw
Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .
Full Information
NCT ID
NCT02139007
First Posted
May 13, 2014
Last Updated
April 4, 2017
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT02139007
Brief Title
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
Acronym
EDGE
Official Title
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuation Arm
Arm Type
Active Comparator
Arm Description
Alendronate continuation arm
Arm Title
Discontinuation Arm
Arm Type
Active Comparator
Arm Description
Alendronate discontinuation arm
Intervention Type
Drug
Intervention Name(s)
Alendronate
Primary Outcome Measure Information:
Title
All Study Sites--Length of Contracting Procedures
Description
Mean time Between Clinical Site Recruitment and Contract Execution
Time Frame
Length of time Between Clinical Site Recruitment and Contract Execution
Title
All Study Sites--Length of Time to Site IRB Approval
Description
Mean time to gain site IRB approval
Time Frame
Length of time to site IRB approval
Title
All Study Sites-Length of Time to 1st Participant Enrolled
Description
Mean time from study initiation to 1st participant enrolled.
Time Frame
Length of time t for sites to recruit/enroll 1st participant
Secondary Outcome Measure Information:
Title
Clinical Fracture Rate
Description
Patient reported fracture rate at 6 months following enrollment via survey.
Time Frame
Baseline to 6 months following enrollment
Title
Atypical Femoral Fracture
Description
Patient reported fracture rate at 6 months after enrollment via follow-up survey
Time Frame
Baseline to 6 months following enrollment
Title
Osteonecrosis of the Jaw
Description
Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .
Time Frame
Baseline to 6 months following enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Females 65+
2.3+ years of alendronate (Fosamax/Binosto) use
3. Valid social security number
Exclusion Criteria:
History of any other metabolic bone condition, such as Paget Disease of Bone
Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.
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)?
HIV positive
Involved in a conflicting (investigational drug) clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth G Saag, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
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