Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention - Workshop Agenda | P2P | ODP

Day 1

Introductory Session

8:30 a.m.

Opening Remarks

Stephen I. Katz, M.D., Ph.D.
Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health

8:40 a.m.

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

8:50 a.m.

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

9:00 a.m.

Osteoporotic Fracture Prevention in the United States

Elizabeth Shane, M.D. 
Professor of Medicine
Department of Medicine
Columbia University Medical Center

9:20 a.m.

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

9:45 a.m.

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

10:00 a.m.

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?

10:10 a.m.

Evidence-based Practice Center Presentation – Short-Term Treatments to Prevent Osteoporotic Fractures

Meera Viswanathan, Ph.D. 
Director, RTI-UNC Evidence-based Practice Center

10:30 a.m.

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?

10:50 a.m.

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

11:10 a.m.

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

11:30 a.m.

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

11:50 a.m.

Discussion

Moderated by
Albert Siu, M.D., M.S.P.H.

12:30 p.m.

Lunch

1:30 p.m.

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?

1:50 p.m.

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

2:10 p.m.

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

2:30 p.m.

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

2:50 p.m.

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

3:10 p.m.

Break

3:20 p.m.

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

3:40 p.m.

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

4:00 p.m.

Osteonecrosis of the Jaw (ONJ)

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

4:15 p.m.

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

4:35 p.m.

Discussion

Moderated by
Albert Siu, M.D., M.S.P.H.

5:25 p.m.

Wrap-up and Preview of Day Two

Albert Siu, M.D., M.S.P.H.

5:30 p.m.

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.


Day 2

8:30 a.m.

Welcome

Albert Siu, M.D., M.S.P.H.

Key Question 3

Do drug holidays improve outcomes?

8:35 a.m.

Evidence-based Practice Center Presentation – Osteoporosis Drug Holidays: Benefits, Risk of Harms, and Effect Modifiers

Howard Fink, M.D., M.P.H.
Principal Investigator, Minnesota Evidence-based Practice Center
Minneapolis Veterans Affairs Health Care System

8:55 a.m.

Clinical Perspectives Regarding Drug Holidays Following Bisphosphonate Therapy

Dolores Shoback, M.D. 
Professor of Medicine
University of California, San Francisco

9:15 a.m.

Tools to Guide Decisions Regarding Long-Term Treatment

Richard Eastell, M.D. 
Professor and Head of the Academic Unit of Bone Metabolism
Director of the Mellanby Centre for Bone Research
The University of Sheffield, UK

9:35 a.m.

Discussion

Moderated by
Albert Siu, M.D., M.S.P.H.

Key Question 4, Part 2:

What patient and clinician factors impact the use of and adherence to osteoporotic drugs?

Overcoming Barriers to Drug Therapy

10:15 a.m.

Bridging the Gap: Research Knowledge to Practice

Paul D. Miller, M.D. 
Distinguished Clinical Professor of Medicine, University of Colorado Health Sciences Center
Medical Director, Colorado Center for Bone Research
Panorama Orthopedics & Spine Center

10:30 a.m.

Recommendations for the Diagnosis and Management of Osteoporosis

Marc C. Hochberg, M.D., M.P.H. 
Professor of Medicine and Epidemiology and Public Health
Department of Medicine
University of Maryland School of Medicine

10:45 a.m.

Break

10:55 a.m.

Implementing Fracture Prevention Strategies: Patient and Provider Approaches

Kenneth Saag, M.D., M.Sc. 
Jane Knight Lowe Professor of Medicine
Department of Medicine, Division of Clinical Immunology and Rheumatology
The University of Alabama at Birmingham

11:15 a.m.

Osteoporosis Improvement Across the Provider Spectrum: Implementation and Economics

Daniel H. Solomon, M.D., M.P.H. 
Professor of Medicine
Department of Rheumatology
Brigham and Women's Hospital, Harvard Medical School

11:35 a.m.

Predicting Fractures with Surrogate Markers

Douglas C. Bauer, M.D. 
Professor of Medicine and Epidemiology and Biostatistics
Division of General Internal Medicine
University of California, San Francisco

11:55 a.m.

Moving Forward with Fracture Prevention

Jane Cauley, Dr.P.H. 
Distinguished Professor 
Department of Epidemiology
University of Pittsburgh

12:15 p.m.

Discussion

Moderated by
Albert Siu, M.D., M.S.P.H.

Conclusion

12:55 p.m.

Moving Forward Down the Pathway to Prevention

Marie Bernard, M.D.
Deputy Director
National Institute on Aging
National Institutes of Health

1:05 p.m.

Review of Next Steps, Instructions to Panel, and Adjourn

Albert Siu, M.D., M.S.P.H.

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.

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Workshop speakers
P2P Workshop Speakers NIH/Andrew Propp