Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

Osteoporosis Clinical Trial

— EDGE  

Official title:

Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139007
• Other study ID #: F120404006
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2014
• Last updated: November 2, 2016
• Start date: June 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. This pilot study is 6 months in length.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 100 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Alendronate

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical site recruitment rate	Ability to recruit clinical trial sites for this pilot study.	6 months following enrollment	No
Primary	Participant recruitment rate	Rate of participant recruitment into this pilot study.	6 months following enrollment	No
Primary	Contracting and procedures	Time spent on contracting and initiating sites for this clinical study.	6 months following enrollment	No
Primary	Administrative procedures	Evaluation of all University of Alabama at Birmingham administrative procedures with this pilot study ie. time to complete contracting, time to complete Institutional Review Board/human subjects training verification for study sites.	6 months following enrollment.	No
Secondary	Osteonecrosis of the jaw	Via follow-up survey patients will self report diagnoses of osteonecrosis of the jaw.	6 months following enrollment	Yes
Secondary	Atypical femoral fracture	Patient reported fracture rate at 6 months after enrollment via survey.	6 months following enrollment	Yes
Secondary	Clinical fracture rate	Patient reported fracture rate at 6 months following enrollment via survey.	6 months following enrollment	Yes