Buffalo Translational Consortium News

Genetics are key to hormone therapy lowering risk of broken bones in older women

Posted on 04/24/17 at 01:51 pm
Heather Ochs-Balcom, associate professor of epidemiology and environmental health, University at Buffalo. Photo: Douglas Levere

UB-led study of postmenopausal women finds that those at highest genetic risk of fracture benefit most from HT

BUFFALO, N.Y. – Women at the highest genetic risk for fracture benefit the most from hormone therapy, according to a first-of-its-kind study led by researchers at the University at Buffalo.

The study included nearly 10,000 participants from the Women’s Health Initiative (WHI), a national, long-term study of more than 150,000 women.

“We found that women who are genetically at the highest fracture risk can enjoy the greatest protection from fracture when they use hormone therapy,” said Heather Ochs-Balcom, associate professor of epidemiology and environmental health in UB’s School of Public Health and Health Professions, who led the research team.

Study PDF available here.

The findings were published online ahead of print in the Journal of Clinical Endocrinology and Metabolism. The paper’s first author, Youjin Wang, conducted the research as a doctoral candidate in epidemiology and environmental health at UB.

“This study provides a better understanding of who can benefit the most in terms of bone health from hormone therapy use,” Ochs-Balcom said, adding that the results have implications for personalized medicine. “It’s important information as women and their doctors make decisions about hormone therapy use.”

The study, believed to be the first to investigate gene-hormone therapy interaction on fracture in postmenopausal white women, utilizes the largest set of known genes linked to fracture risk from a meta-analysis of genome-wide association studies.

Researchers looked at a subset of 9,922 women from among the more than 27,000 who had participated in WHI hormone therapy clinical trials. They wondered whether women who are more genetically susceptible to fractures could benefit from hormone therapy.

“This is important because, as previous WHI studies have identified, there are risks and benefits with hormone therapy,” Ochs-Balcom said. “This is where precision or personalized medicine comes in — the attempt to get the right drugs to the right person to ensure the most benefit and least harm.”

As women age, their bone mineral density (BMD) decreases, leaving them at greater risk of breaking bones from falling, which also increases as they age. But some women also are more genetically prone to fractures.

“Our study represents a first look at how inherited predisposition to fracture is related to hormone therapy use,” said Ochs-Balcom, who also holds a faculty appointment in the Department of Genetics, Genomics and Bioinformatics in UB’s Jacobs School of Medicine and Biomedical Sciences.

Wang notes that “further studies on gene-therapy interaction are warranted to evaluate the advantages of targeted interventions based on genetic profile.” The research team is currently analyzing other gene-environment interactions and recently published another paper on the association of calcium plus vitamin D supplementation and genetic risk of fracture.

In addition to Wang and Ochs-Balcom, other UB co-authors include Jean Wactawski-Wende, dean of the School of Public Health and Health Professions and SUNY Distinguished Professor and professor of epidemiology and environmental health; and Leah Preus, Kathleen Hovey and Jing Nie from the School of Public Health and Health Professions.

Additional co-authors include Lara Sucheston-Campbell, Rebecca Jackson and Samuel Handelman, The Ohio State University; Rami Nassir, University of California, Davis; and Carolyn Crandall, University of California, Los Angeles.

The Women’s Health Initiative began in 1991 and consisted of a set of clinical trials and an observational study. Combined, they included more than 161,000 generally healthy postmenopausal women aged 50 to 79.

One of 40 WHI centers nationwide, the University at Buffalo serves as the Northeast Regional Center, managing data collection and scientific coordination among nine WHI-affiliated institutions in the mid-Atlantic and Northeast regions. UB has received WHI extension funding to conduct follow-up studies on the original participants, many of whom are now between ages 67 and 100.

The WHI is funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health.

Creative scientists take on recruitment challenge

Posted on 04/04/17 at 12:42 pm
A late-winter snowstorm couldn’t prevent researchers from gathering proposals to improve recruitment strategies.
Workshop facilitator Andy Burnett from Knowinnovation Inc. gives directions to working groups.

 

2017 Creative Scientist Workshop: “Innovations in Recruitment to Clinical Trials,” March 14-15, 2017

A group of about 50 biomedical researchers gathered in Buffalo in March to examine the state-of-the-science on recruitment to clinical trials and to explore approaches for developing and evaluating improved methods.

Participants came from Buffalo Translational Consortium partner institutions and a range of other CTSA hubs and institutions, including the University of Rochester, Vanderbilt University, Johns Hopkins University, University of Pennsylvania, The Ohio State University and Case Western Reserve University.

The need is massive. At present, recruitment of participants represents the single largest obstacle to successful clinical trials. Consensus among this diverse group was reached on at least one topic: the need for more empirical data, rather than guesswork and anecdotes, about what actually does and doesn’t work.

Workshop organizer Larry Hawk, PhD, a professor of psychology at UB who conducts clinical trials to help cigarette smokers kick the habit, reviewed the modest literature on evidence-based best practices in recruitment and led the push to improve it:  “We need to build a research base for better recruitment as opposed to the usual hand-wringing, throwing money at it, et cetera,” he said.

The 2017 Creative Scientist Workshop, “Novel Approaches to Clinical Trials Recruitment,” was sponsored by the University at Buffalo Clinical and Translational Science Institute (supported by the National Center for Advancing Translational Sciences of the NIH under award number UL1TR001412). It was held over two days, despite a late-winter snowstorm that socked most of the East Coast, including Buffalo. Attendees heard from national experts on recruitment strategies and formed small work groups to share ideas and formulate strategies.

The conference employed a facilitated workshop format now being used by the National Science Foundation, National Institutes of Health and the National Center for Advancing Translational Sciences to catalyze scientific innovation. Workshop attendees brought a diverse set of perspectives to the table, presenting a range of informative case studies and suggested best practices. 

CTSI Mentored Career Development Award goes to Jason Davies

Posted on 04/03/17 at 09:42 am
Jason Davies, MD, PhD, assistant professor in the departments of Neurosurgery and Biomedical Informatics

The Clinical and Translational Science Institute (CTSI) announced the presentation of a new CTSI Mentored Career Development Award in March.

Jason Davies, MD, PhD, assistant professor in the departments of Neurosurgery and Biomedical Informatics, Jacobs School of Medicine and Biomedical Sciences, will be researching better ways to predict who is most likely to have a stroke, and who is most likely to recover.

Since strokes have many causes and people are individually very different from one another, it’s difficult to know how much at risk any particular person might be. Davies’ project is designed to develop personalized risk predictions based on the combination of genetics and rich demographic, clinical and social data gleaned from electronic health records. All of these factors will be combined using artificial intelligence techniques to create new predictive models. If shown to be effective, these models could then be used to improve clinical practices and guide future health care policies based on constellations of risk factors that better represent individual patient risk.

Margarita L. Dubocovich, PhD, SUNY distinguished professor and senior associate dean for diversity and inclusion in the Jacobs School of Medicine and Biomedical Sciences, is the program lead of the CTSI Mentored Career Development Award Program. “Dr. Davies’ stellar training in neurological surgery and stroke -- combined with the expert guidance of outstanding mentors and the resources provided by the Clinical and Translational Science Institute -- will synergize his unique and novel research on personalized risk predictions for stroke,” she said.

Davies received his MD and PhD at Stanford University and was a resident in the University of California San Francisco Department of Neurological Surgery program. He joined University at Buffalo Neurosurgery as a fellow in 2015 and was named assistant professor in neurosurgery a year later.

The CTSI Mentored Career Development Award programs provide junior faculty with research and professional development mentoring under the guidance of experienced mentors to help their transition into independently funded clinical and translational investigators. CTSI scholars receive support to cover partial salary and research, tuition and travel costs for up to two years, as they submit for individual K or R awards.

Preference for funding awards is given to research that brings novel approaches towards reducing health disparities in clinical populations and applicants with experiences or attributes, which increase diversity in the clinical and translational workforce. Those goals align with the overall aims of the Clinical and Translational Science Institute.

More information about education and training in clinical and translational research can be found here.

The CTSI award is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award numbers UL1TR001412 to the University at Buffalo. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Clinical Research Office launches CTSI Research Round Table series

Posted on 03/07/17 at 02:59 pm

The University at Buffalo Clinical Research Office (CRO) and the Clinical and Translational Science Institute (CTSI) will begin hosting a bimonthly Research Round Table series at the end of March.

Organized by Jennifer Delmerico and Jami Radtke, the CTSI’s two clinical research facilitators in the CRO, each round table discussion will focus on a topic germane to the research interests of Buffalo Translational Consortium (BTC) investigators while providing an opportunity for open-ended conversation between the guest speaker and attendees.

The first round table, i2b2 for Feasibility and Recruitment, is scheduled for Thursday, March 23 at 3 p.m. in Room 5002 of the CTRC. The guest speaker is Senior Institute for Healthcare Informatics Database Architect Jonathan Blaisure who will be talking about the i2b2 database and dashboard that he helped design.

Register here for the first Research Round Table on March 23.

“The idea is to present important information in an informal setting,” says Delmerico. “We’re hoping to start conversations and help people from across the BTC learn new things and make new connections.”

The round table discussions revive a popular series administered by the CRO that was discontinued several years ago.

Said Radtke: “The hour-long format will be divided between a brief presentation by an invited guest speaker on the topic at hand, followed by a free-form, question-and-answer discussion period.”

Topics under consideration for future round tables include clinical trial recruitment strategies, IRB compliance, Click Basics and ClinicalTrials.gov registration. (Email us below with your requests.)

The i2b2 database provides a powerful new tool to clinical research teams in the BTC for accessing the de-identified electronic health records (EHRs) of some 700,000 UBMD patients. The IHI’s Jon Blaisure will provide a demonstration of how to use the i2b2 dashboard for feasibility studies and recruitment at the inaugural CTSI Research Round Table on March 23. Delmerico and Radtke will be on hand to show researchers how to incorporate i2b2 data into study protocols and IRB submissions, and how to adhere to recruitment policy and best practices.

The remainder of the session will be given over to participants: answering their questions and discussing the issues they want to talk about.

If you can’t make it to the first Round Table at the CTRC in March, don’t worry. They will be presenting follow-up i2b2 demonstrations in May and July at locations to be determined on both the north and south campuses.

CTSI Research Round Table

  • Selected topics relevant to biomedical investigators and research coordinators
  • Opportunity for Q&A and open discussion
  • Meets the last Thursday of the month, every other month
  • Bring your questions, concerns and ideas

March 23 Round Table Session: i2b2 for Feasibility and Recruitment, CTRC room 5002, from 3 to 4 p.m.

Questions or suggestions for future round table topics? Email .(JavaScript must be enabled to view this email address).

Research reported in this program was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR001412 to the University at Buffalo. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

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