Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Alendronate

• Registration Number: NCT02139007
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-15
• Study Start: 2014-06
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Results First Submitted: 2017-02-08
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Results First Posted: 2017-05-12
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discontinuation Arm	Alendronate	Alendronate discontinuation arm
Continuation Arm	Alendronate	Alendronate continuation arm

Primary Outcome Measures

Name	Time	Method
All Study Sites-Length of Time to 1st Participant Enrolled	Length of time t for sites to recruit/enroll 1st participant	Mean time from study initiation to 1st participant enrolled.
All Study Sites--Length of Time to Site IRB Approval	Length of time to site IRB approval	Mean time to gain site IRB approval
All Study Sites--Length of Contracting Procedures	Length of time Between Clinical Site Recruitment and Contract Execution	Mean time Between Clinical Site Recruitment and Contract Execution

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States