Cosman, Felicia

Abstract Disclosure: E.M. Lewiecki: Amgen Inc, Radius Health, Inc. K. Tough DeSapri: Amgen Inc, Radius Health, Inc. S. Denning: Amgen Inc, Radius Health, Inc. S.T. Harris: Amgen Inc, Radius Health, Inc. J.G. Sfeir: None. Y. Wang: Radius Health, Inc. J.A. Chiodo: Radius Health, Inc. F. Cosman: Amgen Inc, Biocon, Curateq, Enterabio, Radius Health, Inc, Theramex, UCB. Objectives: Studies have shown that the sequence of osteoporosis (OP) treatment can affect clinical outcome measures and likelihood of attaining therapeutic targets. The aim of this descriptive study was to evaluate the long-term OP treatment patterns in US patients prescribed anabolic therapies (ie, abaloparatide [ABL], teriparatide [TPTD], romosozumab [ROMO]). Methods: Anonymized patient claims data from a subset of ICON’s Symphony Health Patient Source Integrated Dataverse database was utilized. Men and women, aged ≥50 years with at least one prescription claim for ABL, TPTD, or ROMO from May 1, 2019 to April 30, 2021 were included. The index date was the date of the first anabolic treatment claim. For study inclusion, patients were required to have medical and pharmacy record information from 5 years prior to the start of, and 1 year after discontinuation of, anabolic treatment. Patients with a history of anabolic therapy in the 5 years prior to the index date were excluded. Results: 42,400 patients (ABL, n=16,673; TPTD, n=19,575; ROMO, n=6152) were included, of which 80%–90% were women. Persistence rates were low for all anabolic therapies. Overall mean (standard deviation [SD]) duration was 6.5 (5.8), 6.2 (5.6), and 6.0 (4.5) months for the ABL, TPTD, and ROMO groups, respectively, with approximately 45% of patients in the ABL and TPTD groups and 40% of patients in the ROMO group receiving therapy for ≤3 months. Only 18% (ABL) and 17% (TPTD) of patients received over 12 months of anabolic treatment, and 27% of patients in the ROMO group received over 9 months of treatment. In the 5 years prior to anabolic therapy, 35% (ABL), 34% (TPTD), and 47% (ROMO) of patients had prior OP treatment, with the majority having received an oral bisphosphonate (ABL, 26%; TPTD, 25%; ROMO, 21%) for a mean (SD) treatment duration of 15.8 (13.7), 15.5 (13.3), and 16.6 (14.4) months, respectively. The second most prescribed prior therapy was denosumab (ABL, 7%; TPTD, 7%; ROMO, 24%). In the 12 months after anabolic therapy, only 21% of patients in the ABL and TPTD groups received subsequent OP medication, the majority with either denosumab (9%) or oral BP (9%), and 49% of patients treated with ROMO received subsequent treatment, most of which was with denosumab (36%). Conclusions: The pattern of prescriptions of anabolic therapy in US adults identifies significant gaps in the treatment of skeletal fragility. Despite current clinical practice guidelines, the mean duration of anabolic treatment was less than 7 months, and a large majority of patients did not receive subsequent OP prescription following anabolic therapy. Additional research is needed to understand and overcome the obstacles in applying standard of care practices. Further analyses will reveal the clinical outcomes of these treatment patterns. Presentation: Saturday, July 12, 2025

ABSTRACT Many postmenopausal women treated with teriparatide for osteoporosis have previously received antiresorptive therapy. In women treated with alendronate (ALN) or raloxifene (RLX), adding versus switching to teriparatide produced different responses in areal bone mineral density (aBMD) and biochemistry; the effects of these approaches on volumetric BMD (vBMD) and bone strength are unknown. In this study, postmenopausal women with osteoporosis receiving ALN 70 mg/week (n = 91) or RLX 60 mg/day (n = 77) for ≥18 months were randomly assigned to add or switch to teriparatide 20 µg/day. Quantitative computed tomography scans were performed at baseline, 6 months, and 18 months to assess changes in vBMD; strength was estimated by nonlinear finite element analysis. A statistical plan specifying analyses was approved before assessments were completed. At the spine, median vBMD and strength increased from baseline in all groups (13.2% to 17.5%, p < 0.01); there were no significant differences between the Add and Switch groups. In the RLX stratum, hip vBMD and strength increased at 6 and 18 months in the Add group but only at 18 months in the Switch group (Strength, Month 18: 2.7% Add group, p < 0.01 and 3.4% Switch group, p < 0.05). In the ALN stratum, hip vBMD increased in the Add but not in the Switch group (0.9% versus –0.5% at 6 months and 2.2% versus 0.0% at 18 months, both p ≤ 0.004 group difference). At 18 months, hip strength increased in the Add group (2.7%, p < 0.01) but not in the Switch group (0%); however, the difference between groups was not significant (p = 0.076). Adding or switching to teriparatide conferred similar benefits on spine strength in postmenopausal women with osteoporosis pretreated with ALN or RLX. Increases in hip strength were more variable. In RLX-treated women, strength increased more quickly in the Add group; in ALN-treated women, a significant increase in strength compared with baseline was seen only in the Add group.

Objective: The aim of the study was to assess adding vs. switching to teriparatide 20μg/d in patients on alendronate or raloxifene. Design: We conducted a randomized, open-label trial. Patients and Interventions: Postmenopausal women with osteoporosis on alendronate or raloxifene for at least 18 months added teriparatide (Add groups) or switched to teriparatide (Switch groups) for 18 months. Main Outcome Measures: We measured bone turnover markers (BTM) and bone mineral density (BMD). Results: In the alendronate stratum, increases in BTM were smaller in the Add vs. Switch group [6-month PINP (64 vs. 401%); bone ALP (15 vs. 71%); βCTX (27 vs. 250%); all P < 0.001]. However, at 6 months, total hip BMD increased more in the Add vs. Switch group (1.4 vs. −0.8%; P = 0.002). In the Add vs. Switch group, 18-month BMD increments were higher in lumbar spine (8.4 vs. 4.8%; P = 0.003) and total hip (3.2 vs. 0.9%; P = 0.02), but not in femoral neck (2.7 vs. 2.3%; P = 0.75). In the raloxifene stratum, increases in BTM were also smaller in the Add vs. Switch group [6-month PINP (131 vs. 259%; P < 0.001), bone ALP (31 vs. 44%; P = 0.035), and βCTX (67 vs. 144%; P = 0.001)]. At 6 months, total hip BMD increase was greater in the Add vs. Switch group (1.8 vs. 0.5%; P = 0.028). At 18 months, increases in lumbar spine (9.2 vs. 8.1%), total hip (2.8 vs. 1.8%), and femoral neck (3.8 vs. 2.2%) were not significantly different between groups. Conclusions: In women with osteoporosis treated with antiresorptives, greater bone turnover increases were achieved by switching to teriparatide, whereas greater BMD increases were achieved by adding teriparatide. In patients treated with alendronate or raloxifene, adding teriparatide results in a greater bone mineral density response, and appears to be at least as safe as switching to teriparatide.