Osteoporosis | Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
Osteoporosis research study
What is the primary objective of this 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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Continuation ArmAlendronate continuation arm
Discontinuation ArmAlendronate discontinuation arm
Start Date: June 2014
Completed Date: July 2016
Phase: Phase 4
Primary Outcome: All Study Sites--Length of Contracting Procedures
Secondary Outcome: Clinical Fracture Rate
Study sponsors, principal investigator, and references
Principal Investigator: Kenneth G Saag, MD
Lead Sponsor: University of Alabama at Birmingham