Endpoint comparison for bone mineral density measurements in North Central Cancer Treatment Group cancer clinical trials N02C1 and N03CC (Alliance)

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dc.contributor.authorAlliance Clinical Trials Oncology
dc.contributor.otherMayo Clinic
dc.contributor.otherMayo Clinic Phoenix
dc.contributor.otherUniversity of Alabama Tuscaloosa
dc.date.accessioned2023-09-28T19:36:26Z
dc.date.available2023-09-28T19:36:26Z
dc.date.issued2015
dc.description.abstractBone mineral density (BMD) measurement can vary depending upon anatomical site, machine, and normative values used. This analysis compared different BMD endpoints in two clinical trials. Trial results differed across endpoints. Future clinical trials should consider inclusion of multiple endpoints in sensitivity analysis to ensure sound overall study conclusions. Introduction Methodological issues hamper efficacy assessment of osteoporosis prevention agents in cancer survivors. Osteoporosis diagnosis can vary depending upon which bone mineral density (BMD) anatomical site and machine is used and which set of normative values are applied. This analysis compared different endpoints for osteoporosis treatment efficacy assessment in two clinical studies. Methods Data from North Central Cancer Treatment Group phase III clinical trials N02C1 and N03CC (Alliance) were employed involving 774 patients each comparing two treatments for osteoporosis prevention. Endpoints for three anatomical sites included raw BMD score (RawBMD); raw machine-based, sample-standardized, and reference population-standardized T scores (RawT, TSamp, TRef); and standard normal percentile corresponding to the reference population-standardized T score (TPerc). For each, treatment arm comparison was carried out using three statistical tests using change and percentage change from baseline (CB, %CB) at 1 year. Results Baseline correlations among endpoints ranged from 0.79 to 1.00. RawBMD and TPerc produced more statistically significant results (14 and 19 each out of 36 tests) compared to RawT (11/36), TSamp (8/36), and TRef (7/36). Spine produced the most statistically significant results (26/60) relative to femoral neck (20/60) and total hip (13/60). Lastly, CB resulted in 44 statistically significant results out of 90 tests, whereas %CB resulted in only 15 significant results. Conclusions Treatment comparisons and interpretations were different across endpoints and anatomical sites. Transforming via sample statistics provided similar results as transforming via reference or machine-based norms. However, RawBMD and TPerc may be more sensitive to change as clinical trial endpoints.en_US
dc.format.mediumelectronic
dc.format.mimetypeapplication/pdf
dc.identifier.citationDueck, A. C., Singh, J., Atherton, P., Liu, H., Novotny, P., Hines, S., Loprinzi, C. L., Perez, E. A., Tan, A., Burger, K., Zhao, X., Diekmann, B., & Sloan, J. A. (2015). Endpoint comparison for bone mineral density measurements in North Central Cancer Treatment Group cancer clinical trials N02C1 and N03CC (Alliance). In Osteoporosis International (Vol. 26, Issue 7, pp. 1971–1977). Springer Science and Business Media LLC. https://doi.org/10.1007/s00198-015-3091-4
dc.identifier.doi10.1007/s00198-015-3091-4
dc.identifier.orcidhttps://orcid.org/0000-0003-3485-0006
dc.identifier.urihttps://ir.ua.edu/handle/123456789/11574
dc.languageEnglish
dc.language.isoen_US
dc.publisherSpringer
dc.subjectBone mineral density
dc.subjectBreast cancer
dc.subjectCancer survivorship
dc.subjectEndpoints
dc.subjectOsteoporosis
dc.subjectPOSTMENOPAUSAL WOMEN
dc.subjectOSTEOPOROSIS
dc.subjectPREVENTION
dc.subjectPLACEBO
dc.subjectSPINE
dc.subjectRISK
dc.subjectAGE
dc.subjectEndocrinology & Metabolism
dc.titleEndpoint comparison for bone mineral density measurements in North Central Cancer Treatment Group cancer clinical trials N02C1 and N03CC (Alliance)en_US
dc.typeArticle
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