FRI0467 THE DISTRIBUTION OF PREVALENT AND INCIDENT VERTEBRAL FRACTURES IN THE TERIPARATIDE VERSUS RISEDRONATE “VERO” CLINICAL TRIAL
Authors: Piet Geusens, David Kendler, Astrid Fahrleitner-Pammer, Pedro López-Romero, Fernando Marin
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Biomechanical analyses indicate that compressive load is heterogeneous throughout the thoraco-lumbar spine, with maximal loads during daily activities on T<sub>7</sub>-T<sub>8</sub> and T<sub>11</sub>-L<sub>1</sub>. Population-based studies have shown a bimodal spinal distribution of prevalent and incident vertebral fractures (VFxs) at the mid-thoracic and thoraco-lumbar junction levels. However, prevalence and incidence of individual VFxs according to both their location and severity have not been reported in randomised clinical trials with anti-osteoporosis drugs. <h3>Objectives</h3> The aim of this study was to describe the distribution of prevalent and 12- and 24-month incident new and/or worsening VFxs according to location and severity in the teriparatide versus risedronate VERO clinical trial<sup>1</sup>. <h3>Methods</h3> 1360 postmenopausal women with at least 2 moderate (SQ2: 25% ≤ vertebral body height loss &lt; 40%) or 1 severe (SQ3: vertebral body height loss &gt; 40%) VFx according to the semiquantitative (SQ) scale by Genant<sup> 2</sup>, and a BMD T-score ≤ -1.50 were randomised to SC daily teriparatide (20 μg) or oral weekly risedronate (35 mg) in a double-blind, double-dummy 2-year trial. A new VFx was defined as a vertebral body height loss of at least 20% (and 4 mm) of a vertebra that was unfractured at baseline, based on a 6-point placement of the vertebral bodies from T4 to L4, and confirmed by an increase by 1 or more severity grades according to the SQ scale<sup>2</sup>. Worsening of a baseline pre-existing fracture was diagnosed if the decrease in vertebral height was at least 1 severity grade in the SQ assessment. Vertebrae with Schmorl's nodules, Scheuermann's disease and platyspondyly were excluded. Spine x-rays were centrally assessed by radiologists at BioClinica. <h3>Results</h3> Mean (SD) age was 72.1 (8.7) years (min-max: 45-93 years). Spine x-rays were available at baseline, 12, and 24 months for 1,360, 1,159 and 1,049 patients respectively, for a total of 17,413, 14,987 and 13,454 evaluable vertebral bodies. The location of the prevalent VFx by SQ severity degree is shown in Fig.1. At baseline, VFxs were preferentially located at L<sub>1</sub>, T<sub>12</sub>, L<sub>2</sub>, T<sub>11</sub> and T<sub>8</sub> (38.5%, 37.4%, 25.3%, 23.5% and 23.1% of the patients, respectively). A total of 524 (3.0%) of all the assessed vertebral bodies had a fracture at L<sub>1,</sub> the most frequently affected level. There were 126 new and/or worsened incident VFxs during the course of the study (35 in the teriparatide and 91 in the risedronate groups) affecting 100 patients (9.5%) at 24 months. Eighty-nine of these patients presented a new moderate (SQ2) or severe (SQ3) incident VFx. The most frequently fractured vertebral body was T<sub>12</sub> (1.6% of patients), followed by L<sub>1</sub> and T<sub>11</sub> (1.3% both), T<sub>9</sub> (1.2%) and T8 (1.1%). The frequency of incident VFx was lower at all levels with teriparatide (Fig.2). T<sub>12</sub> was also the most frequently fractured vertebral body at 12 months of follow-up (0.7% of patients). <h3>Conclusion</h3> These results from the VERO clinical trial confirm previous results from epidemiological studies that VFxs occur most frequently in the mid-thoracic and thoraco-lumbar regions of the spine. Given the study eligibility criteria, mild (SQ1) VFxs are likely under-represented. Teriparatide is more effective in reducing the incidence of the commonest VFxs (T<sub>12</sub>, L<sub>1</sub>) as compared to risedronate. <h3>References</h3> [1] Kendler DL, et al. Lancet (2018);391:230. [2] Genant HK, et al. J Bone Miner Res (1993);8:1137. <h3>Disclosure of Interests</h3> Piet Geusens Grant/research support from: Research support, consultant and/or speaker fees from: Pfizer, Abbott, Eli Lilly, Amgen, MSD, Roche, UCB, BMS, Novartis, Will-Pharma, Grant/research support from: Pfizer, Abbott, Lilly, Amgen, MSD, Will, Bio Minerals and Roche, Consultant for: Research support, consultant and/or speaker fees from: Pfizer, Abbott, Eli Lilly, Amgen, MSD, Roche, UCB, BMS, Novartis, Will-Pharma, Speakers bureau: Research support, consultant and/or speaker fees from: Pfizer, Abbott, Eli Lilly, Amgen, MSD, Roche, UCB, BMS, Novartis, Will-Pharma, Speakers bureau: Pfizer, Abbott, Lilly, Amgen, MSD, Will, Bio Minerals and Roche, David Kendler Grant/research support from: Research grants, and/or consultant fees from: Amgen, Lilly, AstraZeneca, Astellas, UCB, Consultant for: Research grants, and/or consultant fees from: Amgen, Lilly, AstraZeneca, Astellas, UCB, Speakers bureau: Research grants, and/or consultant fees from: Amgen, Lilly, AstraZeneca, Astellas, UCB, Astrid Fahrleitner-Pammer Speakers bureau: Speaker fees from: Amgen, Alexion, BMS, Lilly, Fresenius, Pedro López-Romero Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Fernando Marin Shareholder of: Lilly, Employee of: Lilly