Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
EDGE
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
May 12, 2017
CompletedMay 12, 2017
April 1, 2017
2 years
May 13, 2014
February 8, 2017
April 4, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
All Study Sites--Length of Contracting Procedures
Mean time Between Clinical Site Recruitment and Contract Execution
Length of 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
Length of time to site IRB approval
All Study Sites-Length of Time to 1st Participant Enrolled
Mean time from study initiation to 1st participant enrolled.
Length of time t for sites to recruit/enroll 1st participant
Secondary Outcomes (3)
Clinical Fracture Rate
Baseline to 6 months following enrollment
Atypical Femoral Fracture
Baseline to 6 months following enrollment
Osteonecrosis of the Jaw
Baseline to 6 months following enrollment
Study Arms (2)
Continuation Arm
ACTIVE COMPARATORAlendronate continuation arm
Discontinuation Arm
ACTIVE COMPARATORAlendronate discontinuation arm
Interventions
Eligibility Criteria
You may qualify if:
- Females 65+
- + years of alendronate (Fosamax/Binosto) use
- \. Valid social security number
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeff Foster
- Organization
- UAB
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth G Saag, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
May 13, 2014
First Posted
May 15, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
May 12, 2017
Results First Posted
May 12, 2017
Record last verified: 2017-04