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Both cancer and therapies used in the treatment of cancer can have significant deleterious effects on the skeleton, increasing the risks for both bone loss and fracture development. While advancements in cancer therapies have resulted in enhanced cancer survivorship for patients with many types of malignancies, it is increasingly recognized that efforts to reduce bone loss and limit fractures must be considered for nearly all patients undergoing cancer therapy in order to diminish the anticipated future skeletal consequences. To date, most studies examining the impact of cancer therapies on skeletal outcomes have focused on endocrine-associated cancers of the breast and prostate, with more recent advances in our understanding of bone loss and fracture risk in other malignancies. Pharmacologic efforts to limit the adverse effects of cancer therapies on bone have nearly universally employed anti-resorptive approaches, although studies have frequently relied on surrogate outcomes such as changes in bone mineral density or bone turnover markers, rather than on fractures or other skeletal-related events, as primary study endpoints. Compounding current deficiencies for the provision of optimal care is the recognition that despite clearly written and straightforward society-based guidelines, vulnerable eligible patients are very often neither identified nor provided with appropriate treatments to limit the skeletal impact of their cancer therapies. KEYWORDS androgen deprivation therapy, aromatase inhibitor, bone loss, breast cancer, myeloma, prostate cancer

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Background Monoclonal gammopathy of unknown significance (MGUS) is a common clinical finding, affecting greater than 3% of adults age 50 years or older. There is good epidemiological evidence that patients with MGUS suffer from significantly increased fracture risk. There are, however, no guidelines for evaluation and/or management of skeletal health in patients with MGUS. Trabecular bone score (TBS), a texture index derived from standard lumbar spine (LS) DXA images, provides information about the underlying trabecular bone microarchitecture independent of bone mineral density (BMD). We hypothesized that patients with MGUS have reduced trabecular microarchitecture that would be reflected by lower TBS, findings that might alter skeletal clinical care decisions. Methods We retrospectively identified 115 adult patients diagnosed with MGUS (cases) between 2005 and 2018 who had a LS DXA within 24 months prior to MGUS diagnosis. MGUS diagnosis was as defined by the 2003 International Myeloma Working Group criteria. A control group was identified, matched 1:1 for sex, age (±5 years) and BMI (± 2 kg/m 2 ). Exclusion criteria included the presence of primary or metastatic bone malignancy, multiple myeloma, exposure to skeletal anti-resorptive or anabolic agents, or exposure to glucocorticoids for > 3 months. TBS analysis was performed retrospectively using TBS iNsight v3.0 software. TBS values were categorized as low (<1.20), intermediate (1.20 - 1.35) or normal (>1.35). Results Cases had a median age of 69.7 years (IQR 63.7 - 75.8; p=0.98 for cases vs. controls) and were predominantly Caucasian (96%; n=111), men (77%; n=89), and had a median BMI of 28.3 kg/m 2 (25.5 - 32.4; p=0.92). BMD was performed after a median of 24 months from time of MGUS diagnosis (0 - 68 months). Cases had significantly higher incident fractures compared to controls (14 vs. 7, respectively, p<0.05). There was no difference between cases and controls with respect to TBS categorization (low 23 vs. 15%; intermediate 42 vs. 41%; normal 35 vs. 44%; p=0.22) or LS T-scores (-0.30 vs. +0.22, p=0.16). Although fractures occurred in controls with significantly lower TBS values (1.17 vs. 1.34 in controls with vs. without fracture, respectively, p <0.01), this was not the case in patients with MGUS (TBS 1.28 vs. 1.31 in cases with vs. without fractures, p=0.97). Similarly, there was no difference in LS T-scores in cases with or without fractures (0.29 vs. -0.4, respectively, p=0.3). Conclusion Despite MGUS patients having a significantly increased risk of fracture compared to age-, sex- and BMI-matched controls, neither BMD nor TBS, obtained within 2 years of MGUS diagnosis, were able to risk stratify patients. Indeed, unlike controls, patients with MGUS tend to fracture despite a normal BMD and an intermediate or normal TBS value. More advanced non-invasive measures of bone quality and finite element ana...