OSTEOPOROSIS BIOMARKERS AND SURROGATE ENDPOINTS

Objectives

  • Assess the current status of biomarkers as surrogate endpoints in clinical trials of osteoporosis interventions
  • Address future needs and opportunities in the assessment of bone structure and function using imaging technologies
  • Translate advances in the understanding of osteoporosis pathogenesis into improved clinical measures to assess change in bone mineralization status
  • Consider current measures of bone absorption and reabsorption as biomarkers and surrogate endpoints in osteoporosis clinical trials
  • Develop strategies to stimulate research on biomarkers and their use as surrogate endpoints in clinical trials for osteoporosis interventions

Agenda

Moderators: Steven R. Cummings, M.D., University of California, San Francisco
Sherry Sherman, Ph.D., National Institute on Aging
Joan McGowan, Ph.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases

Introduction and Goals
Surrogate Endpoints for Treatment-Induced Change in Risk of Osteoporotic Fractures
Steven R. Cummings, M.D.

Osteoporosis: Biomarkers and Surrogate Endpoints
Samarendra N. Dutta, M.D., Ph.D.

Session I. Consideration of Potential Surrogate Endpoints for Osteoporosis Interventions

Is Change in Bone Mineral Density an Adequate Surrogate for Assessing the Effect of Antiresorptive Medications on Fracture Risk?
Dennis M. Black, Ph.D., University of California, San Francisco

Quantitative Ultrasound as a Surrogate Endpoint for Fracture Risk in Osteoporosis Studies
Mary L. Bouxsein, Ph.D., Beth Israel Deaconess Medical Center

Assessment of Trabecular Bone Using Magnetic Resonance Imaging: Role in the Study of Osteoporosis
Sharmila Majumdar, Ph.D., University of California, San Francisco

Radiographically Detected Vertebral Deformities and Loss of Stature as Surrogate Endpoints in Osteoporosis
Michael C. Nevitt, Ph.D., University of California, San Francisco

Discussant: Michael Parfitt, M.D., University of Arkansas for Medical Sciences

General Discussion

Session II. Biological Markers of Bone Turnover

Biological Markers of Bone Turnover: Clinical Value of Biochemical Markers
Richard Eastell, M.D., University of Sheffield, United Kingdom.

Discussant: David Karpf, M.D., Roche Pharmaceuticals

General Discussion and Summary of Research Recommendations

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