Elizabeth A Hibler1, James Kauderer, Mark H Greene, Gustavo C Rodriguez, David S Alberts. 1. 1Division of Epidemiology, Department of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN 2Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 3NRG Oncology/Gynecologic Oncology Group, Statistics and Data Center, Roswell Park Cancer Institute, Buffalo, NY 4National Cancer Institute, Clinical Genetics Branch, Bethesda, MD 5Northshore University Health, Kellogg Cancer Center, Evanston, IL 6University of Arizona, University of Arizona Cancer Center, Tucson, AZ.
Abstract
OBJECTIVE:Women undergoingpremenopausal oophorectomy for a variety of reasons, including to reduce ovarian or breast cancer risk were evaluated for accelerated bone loss. METHODS: The Gynecologic Oncology Group (GOG)-0215 randomized phase-II trial of zoledronic acid was initiated to determine if postoophorectomy bisphosphonate therapy could prevent this bone loss. The study was closed after slow accrual prevented evaluation of the primary study endpoint. We analyzed changes in bone mineral density (BMD) among the 80 women randomized to the observation arm of this study, as measured 3, 9, and 18 months postenrollment. RESULTS: The mean change in BMD from baseline to 18 months was -0.09 (95% CI, -0.12 to -0.07), -0.05 (95% CI, -0.07 to -0.03), and -0.06 (95% CI, -0.07 to -0.05) g/cm across the lumbar spine, right hip, and left hip, respectively. This represents a BMD decrease of -8.5% for the lumbar spine and -5.7% for both the right and left hips from baseline to 18 months' observation. CONCLUSIONS: These results demonstrate that premenopausal women undergoingoophorectomy clearly experience bone loss, an adverse effect of oophorectomy, which requires attention and active management. BMD should be monitored postoophorectomy, and treated per standard practice guidelines. Future studies will be required to determine if early treatment can mitigate fracture risk, and to test promising therapeutic interventions and novel prevention strategies, such as increased physical activity or alternative medications, in randomized trials.
RCT Entities:
OBJECTIVE:Women undergoing premenopausal oophorectomy for a variety of reasons, including to reduce ovarian or breast cancer risk were evaluated for accelerated bone loss. METHODS: The Gynecologic Oncology Group (GOG)-0215 randomized phase-II trial of zoledronic acid was initiated to determine if postoophorectomy bisphosphonate therapy could prevent this bone loss. The study was closed after slow accrual prevented evaluation of the primary study endpoint. We analyzed changes in bone mineral density (BMD) among the 80 women randomized to the observation arm of this study, as measured 3, 9, and 18 months postenrollment. RESULTS: The mean change in BMD from baseline to 18 months was -0.09 (95% CI, -0.12 to -0.07), -0.05 (95% CI, -0.07 to -0.03), and -0.06 (95% CI, -0.07 to -0.05) g/cm across the lumbar spine, right hip, and left hip, respectively. This represents a BMD decrease of -8.5% for the lumbar spine and -5.7% for both the right and left hips from baseline to 18 months' observation. CONCLUSIONS: These results demonstrate that premenopausal women undergoing oophorectomy clearly experience bone loss, an adverse effect of oophorectomy, which requires attention and active management. BMD should be monitored postoophorectomy, and treated per standard practice guidelines. Future studies will be required to determine if early treatment can mitigate fracture risk, and to test promising therapeutic interventions and novel prevention strategies, such as increased physical activity or alternative medications, in randomized trials.
Authors: Dennis M Black; Pierre D Delmas; Richard Eastell; Ian R Reid; Steven Boonen; Jane A Cauley; Felicia Cosman; Péter Lakatos; Ping Chung Leung; Zulema Man; Carlos Mautalen; Peter Mesenbrink; Huilin Hu; John Caminis; Karen Tong; Theresa Rosario-Jansen; Joel Krasnow; Trisha F Hue; Deborah Sellmeyer; Erik Fink Eriksen; Steven R Cummings Journal: N Engl J Med Date: 2007-05-03 Impact factor: 91.245
Authors: Nik Noor Kaussar Nik Mohd Hatta; Mohd Said Nurumal; Muhammad Lokman Muhammad Isa; Azlina Daud; Muhammad Ibrahim; Mohd Ariff Sharifudin; Samsul Deraman Journal: Cent Asian J Glob Health Date: 2019-08-07
Authors: Gábor Rubovszky; Judit Kocsis; Katalin Boér; Nataliya Chilingirova; Magdolna Dank; Zsuzsanna Kahán; Dilyara Kaidarova; Erika Kövér; Bibiana Vertáková Krakovská; Károly Máhr; Bela Mriňáková; Béla Pikó; Ivana Božović-Spasojević; Zsolt Horváth Journal: Pathol Oncol Res Date: 2022-07-11 Impact factor: 2.874