UCSF DIABETES, ENDOCRINOLOGY & METABOLISM TRAINING PROGRAM FACULTY RESEARCH SUMMARIES

My interests are in the diagnosis and therapy of osteoporosis, primarily issues involving testing and treatment. I have been involved in several studies investigating novel therapeutic approaches to osteoporosis as follows.

(1) HORIZON Study: This is a randomized trial to examine the effect of an IV infusion of zoledronate (a bisphosphonate) given once per year. A total of about 8000 women will be randomized in 36 countries. UCSF serves as the Coordinating Center and will be responsible for all data analysis and publications, organizing and running the Steering Committee and Data and Safety Monitoring Board (DSMB), adjudication of fracture events (main study outcome), and maintaining a website to be used by study investigators around the world.

(2) Parathyroid Hormone and Alendronate Trial (PaTH): This is a randomized trial which will examine the effect of PTH and alendronate (in various combinations) on bone density, bone markers and fracture risk. This is a national, multi-center collaborative study with 4 clinical centers in which UCSF serves as the Coordinating Center.

(3) Fracture Intervention Long-term Extension (FLEX): This is a randomized follow-up study to the Fracture Intervention Trial in which the women randomized to alendronate will be re-randomized to either alendronate or placebo for 5 additional years. The goal is to assess the long-term effect of alendronate on bone density and fracture risk. UCSF serves as the Coordinating Center for the study.

(4) PTH Once-Weekly Study: This is a randomized trial that will examine the impact of once-weekly parathyroid hormone vs. placebo in increasing BMD and its effect on biochemical parameters. This pilot study will randomize 50 women with low BMD at the Maine Center for Osteoporosis Research and Education (MECORE). UCSF serves as the Coordinating Center for the study.

(5) Study of Osteoporotic Fractures (SOF): This is a cohort study of 9704 women over age 65 designed to identify risk factors for hip and wrist fractures. It is a national, multi-center collaborative study with the Coordinating Center at UCSF.

(6) MROS Study: This cohort study of 5800 men over age 65 is designed to identify risk factors for hip and wrist fractures. This is a national, multi-center (6 centers) collaborative study with the Coordinating Center at UCSF.

(7) Health, Aging and Body Composition (HABC): The observational study examines changes in body composition occurring in men and women ages 70 to 79 and the relationship of these changes to functional status, morbidity and mortality.

Selected References

Black DM, Greenspan SL, Ensrud KE, Palermo L, McGowan JA, Lang TF, Garnero P, Bouxsein ML, Bilezikian JP, Rosen CJ; PaTH Study Investigators (2003). The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med 349(13):1207-15.

Black DM, Bilezikian JP, Ensrud KE, Greenspan SL, Palermo L, Hue T, Lang TF, McGowan JA, Rosen CJ. The Effect of One year of Alendronate Following 1 year of PTH 1-84:PTH and Alendronate (PaTH) Trial (2005). N Engl J Med 353(6):555-65.

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