Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?
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The global burden of osteoporotic fractures is associated with significant morbidity, mortality, and healthcare costs. We examined the ClinicalTrials.gov database to determine whether recently registered clinical trials addressed prevention and treatment in those at high risk for fracture. A dataset of 96,346 trials registered in ClinicalTrials.gov was downloaded on September 27, 2010. At the time of the dataset download, 40,970 interventional trials had been registered since October 1, 2007. The osteoporosis subset comprised 239 interventional trials (0.6%). Those trials evaluating orthopedic procedures were excluded. The primary purpose was treatment in 67.0%, prevention in 20.1%, supportive care in 5.8%, diagnostic in 2.2%, basic science in 3.1%, health services research in 0.9%, and screening in 0.9%. The majority of studies (61.1%) included drug-related interventions. Most trials (56.9%) enrolled only women, 38.9% of trials were open to both men and women, and 4.2% enrolled only men. Roughly one fifth (19.7%) of trials excluded research participants older than 65 years, and 33.5% of trials excluded those older than 75 years. The funding sources were industry in 51.0%, the National Institutes of Health in 6.3%, and other in 42.7%. We found that most osteoporosis-related trials registered from October 2007 through September 2010 examined the efficacy and safety of drug treatment, and fewer trials examined prevention and non-drug interventions. Trials of interventions that are not required to be registered in ClinicalTrials.gov may be underrepresented. Few trials are specifically studying osteoporosis in men and older adults. Recently registered osteoporosis trials may not sufficiently address fracture prevention.
Published Version (Please cite this version)10.1371/journal.pone.0156068
Publication InfoBarnard, Karen; Lakey, Wanda Cook; Batch, Bryan Courtney; Chiswell, Karen; Tasneem, Asba; & Green, Jennifer Brigitte (2016). Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?. PLoS One, 11(5). pp. e0156068. 10.1371/journal.pone.0156068. Retrieved from http://hdl.handle.net/10161/13803.
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Assistant Professor of Medicine
Associate Professor of Medicine
Type 2 Diabetes, Obesity/Overweight, Behavior change, Non-pharmacologic intervention, Health disparities
Ph.D., North Carolina State University - 2007I work closely with clinical and quantitative colleagues to provide statistical leadership, guidance and mentoring on the design, execution, and analysis of clinical research studies. My work includes design and analysis of observational studies (including large cardiovascular registries, and clinical care databases linke
Professor of Medicine
Diabetes Mellitus: Prevention strategies, predictors, treatment effects, complications and cardiovascular outcomes. Utilization of EHR data to construct tools to improve the care of diabetes and comorbid conditions.
Associate Professor of Medicine
I am an endocrinologist with clinical interests in diabetes and diabetes-related technologies, lipid abnormalities, and bone/calcium disorders. My clinical research interests focus upon therapeutic interventions and management strategies for diabetes and lipid disorders.
Clinical Trials Project Leader II
Ph.D., University of Illinois at Urbana-Champaign - 2005 My overarching goal is to facilitate open science and open access of research data by providing thought leadership, guidance, and support to Duke researchers in data sharing. I work with Research Investigators and Statistical Scientists to manage data-driven projects. My work includes overseeing implementation of innovative software solutions in pragmatic clinical tr
Alphabetical list of authors with Scholars@Duke profiles.