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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Alendronate

Study type: Interventional

Funder types: Other

Identifiers

NCT02139007

F120404006

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: Female

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Continuation Arm

Active Comparator group

Description:

Alendronate continuation arm

Treatment:

Drug: Alendronate

Discontinuation Arm

Active Comparator group

Description:

Alendronate discontinuation arm

Treatment:

Drug: Alendronate