Previous subgroup analyses from the ACTIVE trial in women with postmenopausal osteoporosis (NCT01343004) using threedimensional (3D)-processing of dual X-ray absorptiometry (DXA) scans indicated greater increases in total hip cortical volumetric bone mineral density (Ct.vBMD) and estimated indices of hip strength following 18 months of abaloparatide (ABL) versus placebo or teriparatide. The current post hoc analyses describe hip 3D-DXA data for ACTIVExtend (NCT01657162), in which 18 months of ABL followed by 24 months of alendronate (ABL/ALN) increased hip and spine areal BMD (aBMD) and reduced fracture risk versus placebo (PBO) followed by ALN (PBO/ALN). In an ACTIVExtend subgroup (ABL/ALN, n = 204; PBO/ALN, n = 202), hip DXA scans retrospectively underwent 3D modeling via 3D-Shaper software. Changes from baseline in cortical and trabecular compartments were calculated for total hip and hip subregions (femoral neck, trochanter, and shaft). Estimated strength indices comprising crosssectional moment of inertia, section modulus, and buckling ratio were calculated for each hip subregion. Correlations between bone turnover marker levels at the time of alendronate initiation and subsequent BMD gains with alendronate were also investigated within each group. Total hip trabecular and cortical 3D-DXA parameters increased from baseline in both groups (all p < 0.001), with greater average increases for ABL/ALN versus PBO/ALN (trabecular vBMD: 10.87% versus 4.3%; cortical thickness: 2.32% versus 1.14%; Ct.vBMD: 3.41% versus 1.86%; cortical surface BMD: 5.82% versus 3.0%; all p < 0.001). Strength indices in the ABL/ALN group improved in all subregions versus baseline (all p < 0.0001) and versus PBO/ALN (all p < 0.02). In the ABL/ALN group, collagen type I N-terminal propeptide (P1NP) levels at the time of alendronate initiation correlated with subsequent percent changes in all 3D-DXA parameters with 24 months of alendronate therapy. In conclusion, sequential ABL/ALN or PBO/ALN treatment improves trabecular and cortical 3D-DXA parameters at the hip, as well as strength indices of hip subregions, with greater increases with ABL/ALN versus PBO/ALN.
142 Background: To evaluate the clinical variables associated with upgrading at confirmatory biopsy among a racially-diverse group of men with prostate cancer (PCa) who elect Active Surveillance (AS). Methods: Following IRB approval, of the more than 260 men from our multi-institutional prospective AS database we identified 140 that had undergone at least 1 confirmatory biopsy since their initial diagnosis. Patients whose diagnosis was made on TURP, had any Gleason 4 on their initial biopsy or whose initial and confirmatory biopsy were more than 2 years apart were excluded. The analysis cohort included 121 men who had Gleason Score ≤ 6, clinical stage ≤ T2a and PSA ≤ 20 ng/mL. Disease upgrading on confirmatory biopsy was Gleason score ≥ 7. Multiple variables were examined as univariate and MV predictors of upgrading. Results: We identified 121 men who fit inclusion criteria, 55 (45%) African Americans (AA) and 66 non-AA (55%) with a median follow-up of 22 months. The median age was 66, median number of biopsy cores taken at diagnostic biopsy was 12 and median time interval between diagnostic and confirmatory biopsy was 12 months. On confirmatory biopsy, no evidence of disease was noted for 51 (42%) men (26 AA, 25 non-AA), 48 (40%) men (18, AA, 30 non-AA) had findings consistent with their initial biopsy and 22 men (11 AA, 11 non-AA) experienced upgrading at repeat biopsy. Of the 22 (18%) men who were upgraded, 18 (8 AA, 10 non-AA) upgraded to a Gleason score of 7, 3 (2 AA, 1 non-AA) were upgraded to a Gleason score of 8 and 1 (AA) had a Gleason score of 9. In univariate analysis AA race was associated with a greater number of positive cores (p = 0.04) and greater total prostate volume (p = 0.03) at confirmatory biopsy. Multivariate analysis was performed and none of the clinical variables examined (race, age, BMI, PSA, volume, PSAD, number of positive cores, total number of cores, percentage of positive cores, time between biopsies) were associated with upgrading on repeat biopsy. Conclusions: Our findings suggest that race is not associated with an increased risk of upgrading at confirmatory biopsy. AA with low-risk PCa are reasonable candidates for inclusion in most AS protocols and should not be excluded based on race alone.
103 Background: To date, large populations of men from European ancestry have been prospectively evaluated on Active Surveillance (AS), a strategy reserved for low risk prostate cancer (PCa). African Americans (AA) deemed to be candidates for AS have yet to be fully characterized. We sought to determine the similarities and differences of our AS cohort stratified by race. Methods: We identified 308 men from our multi-institutional, prospective AS database were analyzed. Inclusion criteria was PSA < 20ng/mL, Gleason score ≤ 7, and clinical stage ≤ T2a. Men who sought treatment for their PCa or refused subsequent imaging and biopsy were excluded. Univariate analysis was done to analyze racial differences in demographic, clinical and pathologic variables. Results: We identified 308 men, 131 (43%) AA and 177 nonAA (57%). The groups were not significantly different with respect to age; 65 years, BMI 28.4, family history of PCa (22%), prior negative biopsy (21%) and clinical staging (87% T1c). Median follow-up is 25 months (IQR 12-44). Significant differences between the AA and nonAA cohorts did exist at baseline with respect to overall health, suggesting AA having worse overall health. More AA had diabetes (29 vs 14%; p = .03), were smokers (55 vs 29%; p < .01), cardiovascular disease (21 vs 9%) and erectile dysfunction (43 vs 18%; p < .01). Social characteristics also differed within the groups, with AA less likely to be married (47 vs 51%; p = .01). Despite a lack of difference with respect to biopsy Gleason score, AA had higher PSA (5.7 vs 5.0 ng/mL; p = 0.02), lower testosterone levels (250 vs 334 ng/dL; p = 0.05), greater PSA density (0.15 vs 0.12; p < 0.01), and greater linear length of cancer per biopsy core (16 vs 13mm; p < 0.01) at time of diagnosis and initiation of AS. Conclusions: Within our AS cohort, AA have worse overall health and more aggressive PCa features despite meeting inclusion criteria and selecting AS. Further prospective study is needed to determine how these competing factors may impact long term outcomes.
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