Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

University of Alabama at Birmingham27 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoporosis

Interventions

AlendronateDRUG

Eligibility

Sex: FEMALEMin age: 65 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

All Study Sites--Length of Contracting Procedures

Mean time Between Clinical Site Recruitment and Contract Execution

Time frame: 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

Time frame: 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.

Time frame: Length of time t for sites to recruit/enroll 1st participant

Secondary Outcomes

Clinical Fracture Rate

Patient reported fracture rate at 6 months following enrollment via survey.

Time frame: Baseline to 6 months following enrollment

Atypical Femoral Fracture

Patient reported fracture rate at 6 months after enrollment via follow-up survey

Time frame: 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 .

Time frame: Baseline to 6 months following enrollment

Data from ClinicalTrials.gov

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