Bone mineral density and biochemical parameters after one year of treatment with denosumab or zoledronate in postmenopausal women with osteoporosis and primary hyperparathyroidism: a pilot study

Kozamernik Katarina Mlekus; Luka Ležaić; Marko Hočevar; Tomaž Kocjan

doi:10.1530/endoabs.110.OC7.1

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Endocrine Abstracts (2025) 110 OC7.1 | DOI: 10.1530/endoabs.110.OC7.1

ECEESPE2025 Oral Communications Oral Communications 7: Bone and Mineral Metabolism (9 abstracts)

Bone mineral density and biochemical parameters after one year of treatment with denosumab or zoledronate in postmenopausal women with osteoporosis and primary hyperparathyroidism: a pilot study

Katarina Mlekus Kozamernik ¹ , Luka Ležaić ² , Marko Hočevar ³ & Tomaž Kocjan ¹

Author affiliations

¹UMC Ljubljana, Faculty of Medicine, University of Ljubljana, Department of Endocrinology, Diabetes and Metabolic Diseases, Ljubljana, Slovenia; ²UMC Ljubljana, Faculty of Medicine, University of Ljubljana, Department of Nuclear Medicine, Ljubljana, Slovenia; ³Institute of Oncology, Faculty of Medicine, University of Ljubljana, Department of Surgical Oncology, Ljubljana, Slovenia

JOINT2255

Background: Optimal medical treatment of postmenopausal women with osteoporosis and primary hyperparathyroidism (PHPT) who decline surgery has not been determined. We compared the therapeutic effects of denosumab or zoledronate in this population.

Methods: Postmenopausal women with osteoporosis and PHPT were randomized 1:1 to treatment with either denosumab 60 mg sc every six months (DMAB group) or zoledronate 5 mg iv once a year (ZOL group) (ClinicalTrials.gov Identifier NCT04085419). Bone mineral density (BMD) at four standard sites and trabecular bone score (TBS) were measured by DXA at baseline and after twelve months (12M). Serum calcium (S-Ca), intact parathyroid hormone (iPTH), and bone turnover markers (C-terminal telopeptide (CTX), N-terminal propeptide of type I procollagen (PINP), and bone-specific alkaline phosphatase (BAP)) were determined at baseline, 3M, 6M, and 12M.

Results: Forty females (aged 73.0 (7.8 SD) years; 22.6 (10.0) years from menopause; BMI 27.77 (5.1) kg/m²) were included. After one year of treatment, LS BMD was significantly and similarly higher in both groups (LS BMD 12M ΔDMAB +0.038 g/cm²; P<0.001 and ΔZOL +0.040 g/cm²; P=0.003). TH BMD was significantly higher only in the DMAB group (TH BMD 12M ΔDMAB +0.036 g/cm²; P=0.006), while FN and 1/3R BMD did not change. All patients together had significantly higher TBS (ΔTBS 12M +0.066; P=0.016). There was a statistically significant decrease of 3M S-Ca in both groups (S-Ca 3M ΔDMAB -0.07 mmol/l; P=0.045, ΔZOL -0.08 mmol/l; P<0.01). The iPTH level increased significantly in both groups at 3M, remained high at 6M, and slowly decreased thereafter, with no statistically significant difference between the groups (iPTH 3M ΔDMAB +61.91 (126.93); P=0.042 vs. ΔZOL +30.24 (56.84) ng/l; P=0.003). CTX, PINP, and BAP decreased significantly in both groups at 3M (CTX 3M ΔDMAB -0.952 (0.639) vs ΔZOL -0.556 (0.439) μg/l; P=0.03; PINP 3M ΔDMAB -75.45 (33.9) vs ΔZOL -54.06 (32.06) μg/l; P=0.003; BAP 3M ΔDMAB -19.72 (8.12) vs ΔZOL -13.68 (9.55) μg/l; P=0.685), and remained low and unchanged thereafter. CTX and PINP at 3M were significantly lower in DMAB group.

Conclusion: One year of denosumab or zoledronate had similar effects on BMD and TBS in postmenopausal women with osteoporosis and PHPT. The effects on S-Ca, iPTH at 3M were also comparable between treatments. Denosumab had a more potent short-term effect on decreasing bone turnover than zoledronate.