Day 1 – October 30, 2018
8:30 a.m. to 5:30 p.m. Eastern Time
Introductory Session
Opening Remarks
Stephen I. Katz, M.D., Ph.D.
Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
Welcome and Charge to the Panel
David M. Murray, Ph.D.
Associate Director of Disease Prevention
Director, Office of Disease Prevention
Division of Program Coordination, Planning, and Strategic Initiatives
Office of the Director
National Institutes of Health
Workshop Overview and Panel Activities
Albert Siu, M.D., M.S.P.H.
Workshop and Panel Chair
Director of Mount Sinai at Home
Professor and Chairman Emeritus, The Brookdale Department of Geriatrics and Palliative Medicine
Icahn School of Medicine at Mount Sinai
Overview of Osteoporotic Fractures and Drugs to Prevent Them
Osteoporotic Fracture Prevention in the United States
Elizabeth Shane, M.D.
Professor of Medicine
Department of Medicine
Columbia University Medical Center
FDA-Approved Pharmacologic Options for Fracture Prevention
Sundeep Khosla, M.D.
Professor of Medicine
Department of Endocrinology and Kogod Center on Aging
Mayo Clinic
9:35 a.m.
Overview of NIH Portfolio on Osteoporotic Fracture Prevention
Faye Chen, Ph.D.
Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
The Translational Pipeline: A Regulatory Perspective
Theresa Kehoe, M.D.
Lead Medical Officer
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Break
Key Question 1:
What are the benefits and risks (including major adverse events) of osteoporotic drugs with short-term use (from first use up to 3-5 years of treatment)? What factors influence outcomes?
Evidence-based Practice Center Presentation – Short-Term Treatments to Prevent Osteoporotic Fractures
Meera Viswanathan, Ph.D.
Director, RTI-UNC Evidence-based Practice Center
Short-Term Drug Therapy for Osteoporotic Fracture Prevention – Balancing Benefits and Risks
Clifford J. Rosen, M.D.
Department of Clinical and Translational Research
Senior Scientist, Maine Medical Center Research Institute
Key Question 4, Part 1:
What patient and clinician factors impact the use of and adherence to osteoporotic drugs?
Short-Term Drug Therapy for Osteoporotic Fracture Prevention – Prescribing in the Primary Care Setting
James M. Gill, M.D., M.P.H.
President and Principal Investigator
Delaware Valley Outcomes Research
Short-Term Drug Therapy for Osteoporotic Fracture Prevention – Acceptance by Patients
Stuart L. Silverman, M.D.
Clinical Professor of Medicine
Cedars-Sinai Medical Center and UCLA School of Medicine
Osteoporosis Medical Center
Drug Therapy for Osteoporotic Fracture Prevention – Improving Adherence
Deborah T. Gold, Ph.D.
Professor of Medical Sociology
Departments of Psychiatry and Behavioral Sciences, Sociology, and Psychology and Neuroscience
Duke University Medical Center
Discussion
Moderated by
Albert Siu, M.D., M.S.P.H.
Lunch
Patients’ Perspectives
Moderated by
Carrie Klabunde, Ph.D.
Senior Advisor for Disease Prevention, P2P Program Team Lead
Division of Program Coordination, Planning and Strategic Initiatives
Office of Disease Prevention
National Institutes of Health
Patient Representatives:
Gerry O’Connor
Barbara Hannah Grufferman
Nancy Ostrove
Key Question 2:
What are the benefits and risks of osteoporotic drugs over the longer term (for treatment periods > 3 years)? What factors influence the outcomes?
Evidence-based Practice Center Presentation – Long-Term Osteoporosis Drug Therapy: Benefits and Effect Modifiers of Benefits
Howard Fink, M.D., M.P.H.
Principal Investigator, Minnesota Evidence-based Practice Center
Minneapolis Veterans Affairs Health Care System
Impact of Long-Term Osteoporosis Treatment and Drug Holidays on Fracture Risk: Evidence from Observational Studies
Dennis Black, Ph.D.Professor
Department of Epidemiology and Biostatistics
University of California, San Francisco
Menopausal Hormone Therapy and Selective Estrogen Receptor Modulators for Prevention and Treatment of Osteoporosis: The Balance of Benefits and Risks
Rebecca D. Jackson, M.D.
Professor
Division of Endocrinology, Diabetes and Metabolism
The Ohio State University, Wexner Medical Center
Fracture Prevention Strategies Beyond Antiresorptives: Anabolics and Combination Therapies
Felicia Cosman, M.D.
Professor of Medicine
Department of Medicine
Columbia University College of Physicians and Surgeons
Break
Evidence-based Practice Center Presentation – Long-term Drug Therapy: Harms and Effect Modifiers of Harms
Howard Fink, M.D., M.P.H.
Principal Investigator, Minnesota Evidence-based Practice Center
Minneapolis Veterans Affairs Health Care System
Rare but Serious Adverse Events Associated with Long-Term Antiresorptive Therapy – Who’s at Risk? How to Manage?
Atypical Femoral Fractures (AFF)
Robert A. Adler, M.D.
Chief, Department of Endocrinology
McGuire Veterans Affairs Medical Center
Professor of Medicine, Virginia Commonwealth University School of Medicine
Tara Aghaloo, D.D.S., M.D., Ph.D.
Professor and Assistant Dean for Clinical Research
Department of Oral and Maxillofacial Surgery
University of California, Los Angeles School of Dentistry
Other Side Effects of Antiresorptive Therapies
Juliet Compston, M.D.
Professor Emeritus of Bone Medicine
Department of Medicine
University of Cambridge School of Clinical Medicine, UK
Discussion
Moderated by
Albert Siu, M.D., M.S.P.H.
Wrap-up and Preview of Day Two
Albert Siu, M.D., M.S.P.H.
Adjourn
Attendees will be responsible for meals and/or light refreshments on their own, at their own cost. The government and/or government contractors are not involved in facilitating the provision of food and/or light refreshments.