MON-813 Efficacy of Zoledronate on Incidence of Major Osteoporotic Fractures in Postmenopausal Osteoporotic Women With and Without Diabetes

Abstract Disclosure: S. Giri: None. S. Kamalanathan: None. R. Govindarajalou: None. D. Naik: None. S. Ali Mondal: None. J. Sahoo: None. Introduction: Zoledronate is primarily beneficial when bone turnover is elevated, such as in the postmenopausal state. The gain in bone mineral density (BMD) is significantly lower in subjects with diabetes mellitus (DM) compared to non-DM subjects due to lower baseline bone turnover in diabetes. Moreover, fractures occur at relatively preserved BMD in DM, making neither BMD nor bone turnover markers (BTMs) reliable for assessing bone health. Few studies have shown that zoledronate increases BMD in DM as well. However, whether this translates to fracture prevention remains unclear. No prospective study has compared its efficacy in terms of fracture outcomes in patients with and without DM. Aims: To assess the effect of zoledronate on major osteoporotic fractures in postmenopausal osteoporotic women with and without diabetes over 5 years. Methods: This prospective cohort study involved postmenopausal women with BMD T-scores of – 2.5 or lower at any site among the femoral neck, hip or, lumbar spine. Participants were divided into two groups: 1) with type 2 DM and 2) without DM. Both groups received annual intravenous zoledronate (4 mg), along with daily 25-hydroxyvitamin D (500 IU) and calcium (1000 mg) orally. A fall prevention template was also provided. Fracture history was documented at each visit, and lateral radiographs of the thoracic and lumbar spine were taken at baseline and annually to detect morphometric vertebral fractures using semi-quantitative method introduced by Genant et al. Women who completed at least 5 years of follow-up were analyzed. The primary endpoint was the number of participants in each group developing new major osteoporotic fractures, including morphometric vertebral and fragility fractures. Secondary endpoints included changes in BMD and BTMs. Results: Initially, 183 women were recruited for the study; among them, 150 women, with a median age of 59 years and a post-menopausal duration of 10 years, completed the study. Of these, 63 had DM and 87 did not. The median diabetes duration was 8 years and mean glycated hemoglobin A1c (HbA1c) was 9.3% at the recruitment of the study. Baseline BMD at the lumbar spine and proximal femur was similar in both groups, but BTMs were lower in women with DM. Eight women with DM and 13 without DM had fracture at the baseline. Participants received 3 to 6 zoledronate infusions over a median follow-up of 63.5 months. A total of 20 new fractures occurred in 15 participants: 8 (12.7%) women in the DM group and 7 (8.0%) women in the non-DM group. The relative risk (RR) of fractures in DM versus non-DM groups was 1.58 [95% CI, 0.60 to 4.13; P= 0.2]. Conclusion: There is no significant difference in incident fracture outcome between women with and without diabetes with yearly once zoledronate over a follow up of 5 years. So, zoledronate is equally effective in preventing fracture in patients with diabetes as non-diabetes postmenopausal osteoporosis patients. Presentation: Monday, July 14, 2025