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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Alendronate

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuation Arm; Alendronate continuation arm	Drug: Alendronate
Active Comparator: Discontinuation Arm; Alendronate discontinuation arm	Drug: Alendronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Fracture Rate	Patient reported fracture rate at 6 months following enrollment via survey.	Baseline to 6 months following enrollment
Atypical Femoral Fracture	Patient reported fracture rate at 6 months after enrollment via follow-up survey	Baseline to 6 months following enrollment
Osteonecrosis of the Jaw	Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .	Baseline to 6 months following enrollment

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Kenneth G Saag, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: F120404006