Background/Purpose: Romosozumab (RMZ) is a recently approved dual-acting drug which has been shown to reduce fracture risk in patients with osteoporosis (OP) in clinical trials. However, data on its use in actual clinical practice remain limited. Our purposes are:-Describe the profile of patients treated with RMZ in realworld clinical practice.-Evaluate its efficacy based on densitometric changes and the incidence of new fractures. -Assess the safety profile of the drug and patient satisfaction.

Methods: This multicentre retrospective observational study aimed to assess the use of RMZ and its efficacy in patients with OP in real-world clinical settings. Data were collected from the medical records of patients treated by their regular rheumatologist at the participating centres and entered into an anonymous electronic database. Demographic data, comorbidities, risk factors for OP development, the number and location of previous fractures and prior treatments performed on the patients were gathered. Laboratory tests and densitometry were conducted before and after treatment. The FRAX index was calculated for all patients prior to starting treatment. The study was approved by the ethics committee at Hospital 12 de Octubre.

Results: A total of 128 women from six centres in the Region of Madrid were included, of whom 81 have completed treatment to date. Baseline patient data are shown in Table 1. The mean age was 69.7 ±12.9 years. The mean BMI was 26.1 ± 6.8, while 39.5% were classified as obese. The most common comorbidities were hypertension and dyslipidaemia (both 35.8%). Most of the patients had no toxic habits. 88.9% had experienced one or more previous fractures, the majority of which were vertebral fractures. The mean FRAX data for hip fracture risk were 9.2 ± 11.1 and for major osteoporotic fracture they were 21.4 ± 14.7. RMZ was used as a second-line treatment in most patients (43.4%). No laboratory test changes were observed during treatment. The densitometric changes found are shown in Table 3, which illustrates the statistically significant differences between the baseline and post-treatment DEXA values for the lumbar spine and hip. Chart 1 shows the treatments after completing RMZSix patients reported adverse effects. The most common were local reactions at the injection site. Treatment was discontinued in two patients due to adverse effects, one due to a severe skin reaction and the other due to a stroke. None of the patients experienced a new fracture during the follow-up period. Patient satisfaction was rated at 4.6 ± 0.6 (scale 0-5).

Conclusion: RMZ is mainly used in women with severe OP, most of whom have experienced several previous fractures and are receiving second or subsequent lines of treatment. It has shown statistically significant improvements in densitometric measurements in the lumbar spine and hip. The majority of adverse effects were mild and no patients experienced new fractures during the follow-up period

Table 1. Baseline characteristics of patients at the start of the study

Table 3. Densitometric data before and after RMZ

Chart 1

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/experience-with-romosozumab-in-women-with-osteoporosis-at-high-risk-of-fracture-in-real-world-clinical-practice/