Abstract

The primary objective is to determine the effect of Aredia on bone loss associated with androgen deprivation. Hormonal therapy is the standard treatment for men with prostate cancer that has spread beyond the prostate. One of the side effects of hormonal therapy is osteoporosis or thinning of the bones. Osteoporosis may result in bone fractures and pain. Aredia is effective at preventing osteoporosis that results from female menopause or treatment with some medications. The effect of Aredia on ostoeporosis that results from hormonal therapy for prostate cancer is not known. The trial will include men with prostate cancer who are about to begin hormonal therapy. Prior to starting hormonal therapy, study participants will be randomized to standard care or treatment with Aredia every three months for two years. In addition to routie medical appointments, study participation will require eight outpatient visits for special testing over two years. The following tests will be performed dduring the trial: physical examinations, medical history, x-rays of bones (bone densitometry and scans), blood and urine tests.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001066-23
Application #
6308022
Study Section
Project Start
1999-12-01
Project End
2000-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
23
Fiscal Year
2000
Total Cost
$575
Indirect Cost

  Institution

Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199

  Publications

Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Fourman, Lindsay T; Czerwonka, Natalia; Shaikh, Sofia D et al. (2018) Insulin-like growth factor 1 inversely relates to monocyte/macrophage activation markers in HIV. AIDS 32:927-932
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Foldyna, Borek; Fourman, Lindsay T; Lu, Michael T et al. (2018) Sex Differences in Subclinical Coronary Atherosclerotic Plaque Among Individuals With HIV on Antiretroviral Therapy. J Acquir Immune Defic Syndr 78:421-428
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Srinivasa, Suman; Lu, Michael T; Fitch, Kathleen V et al. (2018) Epicardial adipose tissue volume and cardiovascular risk indices among asymptomatic women with and without HIV. Antivir Ther 23:1-9

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