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Effect of a single dose of zoledronic acid on bone mineral density and trabecular bone score in Indian postmenopausal osteoporotic women with and without type 2 diabetes mellitus – A prospective cohort pilot study

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Abstract

Purpose

The objectives were to study the effect of a single dose of intravenous (IV) zoledronic acid (ZA) on changes in bone mineral density (BMD) (lumbar spine (LS), hip, & distal forearm), trabecular bone score (TBS) and bone turnover markers (BTMs) in postmenopausal osteoporotic women with and without diabetes over 12 months.

Methods

Patients were divided into two groups: type 2 diabetes mellitus (T2DM) (n = 40) and non-DM (n = 40). Both groups received a single dose of 4 mg IV ZA at baseline. The BMD with TBS and BTMs (β-CTX, sclerostin, P1NP) were measured at baseline, six months, and 12 months.

Results

At baseline, BMD in all three sites was similar in both groups. T2DM patients were older and had lower BTMs than non-DM patients. The mean increase in LS-BMD (gram/cm2) at 12 months in T2DM and the non-DM group was 3.6 ± 4.7% and 6.2 ± 4.7 %, respectively (P = 0.01). However, the age adjusted mean difference in LS BMD increment between two groups at one year was − 2.86 % (−5.02% to −0.69%), P = 0.01. There was a comparable change in BMD at other two sites, BTMs, and TBS in both the groups over one year follow-up.

Conclusion

The gain in the LS-BMD was significantly lower in T2DM group compared to non-DM subjects over 12 months after a single IV infusion of 4 mg ZA. The explanation for this could be low bone turnover in diabetes subjects at baseline.

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Acknowledgements

The manuscript was presented as an e-poster both at the Indian Society for Bone and Mineral Research (ISBMR) Annual Meeting, October 30–31, 2021, at Hyderabad, India, and at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting, October 1–4, 2021 at the San Diego Convention Center in California, USA.

Author contributions

All authors contributed to the study’s conception and design. The data collection, analysis, and interpretation were performed by C.M., G.R., J.S., and S.S.K. All authors revised it critically for important intellectual content and approved the final manuscript.

Funding

This study was funded by both an extramural grant from the endocrine society of India (TG2019015/18-10-2019) and an intramural grant from Jawaharlal Institute of Postgraduate Medical Education and Research (JIP/Res/Intramural/Phs 2 /2018–2019).

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Correspondence to Jayaprakash Sahoo.

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This study was performed in line with the principles of the Declaration of Helsinki after obtaining the Institute Ethics Committee’s approval (JIP/IEC/2018/379 date-28.12.2018).

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Merugu, C., Sahoo, J., Kamalanathan, S. et al. Effect of a single dose of zoledronic acid on bone mineral density and trabecular bone score in Indian postmenopausal osteoporotic women with and without type 2 diabetes mellitus – A prospective cohort pilot study. Endocrine 82, 171–180 (2023). https://doi.org/10.1007/s12020-023-03432-5

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