Skip to main content
OpenTrials
Completed

NCT Number: NCT02139007

Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

65 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.Females 65+

2.3+ years of alendronate (Fosamax/Binosto) use

  • Valid social security number

Exclusion criteria

  • History of any other metabolic bone condition, such as Paget Disease of Bone
  • Currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer.
  • 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)?
  • HIV positive
  • Involved in a conflicting (investigational drug) clinical trial

Treatment and study plan

Alendronate

Drug

Primary outcomes

  1. All Study Sites--Length of Contracting Procedures

    Time frame: Length of time Between Clinical Site Recruitment and Contract Execution

    Mean time Between Clinical Site Recruitment and Contract Execution

  2. All Study Sites--Length of Time to Site IRB Approval

    Time frame: Length of time to site IRB approval

    Mean time to gain site IRB approval

  3. All Study Sites-Length of Time to 1st Participant Enrolled

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

    Mean time from study initiation to 1st participant enrolled.

Secondary outcomes

  1. Clinical Fracture Rate

    Time frame: Baseline to 6 months following enrollment

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

  2. Atypical Femoral Fracture

    Time frame: Baseline to 6 months following enrollment

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

  3. Osteonecrosis of the Jaw

    Time frame: Baseline to 6 months following enrollment

    Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: EDGE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 15, 2014
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.