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Denosumab in treatment-naïve and pre-treated with zoledronic acid postmenopausal women with low bone mass: Effect on bone mineral density and bone turnover markers.
Metabolism. 2015 Oct; 64(10):1291-7.M

Abstract

PURPOSE

To compare denosumab-induced changes in lumbar spine (LS) and femoral neck (FN) bone mineral density (BMD), bone markers and free soluble receptor activator of nuclear factor kappaB ligand (sRANKL) between treatment naïve postmenopausal women with low bone mass (naïve group) and those who were previously treated with a single zoledronic acid infusion (post-Zol group).

PROCEDURES

Procollagen type 1N-terminal propeptide (P1NP), C-terminal cross-linking telopeptide of type 1 collagen (CTx) and sRANKL levels were measured in serum samples obtained at baseline and 3, 6 and 12months after denosumab initiation. LS and FN BMD were measured at baseline and 12months.

RESULTS

LS and FN BMD increased significantly in both naïve and post-Zol group (p<0.001 and p=0.025 vs. p<0.001 and p=0.017, respectively). Despite the higher P1NP and CTx levels in naïve patients at baseline (both p<0.001), denosumab caused comparable decreases in both groups at month 3, which returned to post-Zol group baseline levels at month 6 and 12 in all patients. Similarly, sRANKL levels decreased significantly at month 3 in both groups and returned to baseline levels at months 6 and 12.

CONCLUSIONS

In patients previously treated with zoledronic acid, sequential denosumab treatment is effective in terms of BMD increases and bone turnover suppression. Despite the lower baseline levels in patients pre-treated with zoledronic acid, bone markers are similarly decreased in both groups following denosumab administration and maintain their reversibility. Denosumab reversibly suppresses endogenous free sRANKL levels in both naïve and zoledronic acid pre-treated patients.

Authors+Show Affiliations

Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece. Electronic address: anastath@endo.gr.Second Medical Clinic, Department of Medicine, Aristotle University of Thessaloniki, Ippokration General Hospital, Thessaloniki, Greece.Department of Endocrinology, "Hippokration" General Hospital of Thessaloniki, Thessaloniki, Greece.1st Department of Orthopaedics, 424 General Military Hospital Thessaloniki, Greece.Department of Rheumatology, 424 General Military Hospital, Thessaloniki, Greece.Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.Department of Endocrinology and Diabetes, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

26198440

Citation

Anastasilakis, Athanasios D., et al. "Denosumab in Treatment-naïve and Pre-treated With Zoledronic Acid Postmenopausal Women With Low Bone Mass: Effect On Bone Mineral Density and Bone Turnover Markers." Metabolism: Clinical and Experimental, vol. 64, no. 10, 2015, pp. 1291-7.
Anastasilakis AD, Polyzos SA, Efstathiadou ZA, et al. Denosumab in treatment-naïve and pre-treated with zoledronic acid postmenopausal women with low bone mass: Effect on bone mineral density and bone turnover markers. Metabolism. 2015;64(10):1291-7.
Anastasilakis, A. D., Polyzos, S. A., Efstathiadou, Z. A., Savvidis, M., Sakellariou, G. T., Papatheodorou, A., Kokkoris, P., & Makras, P. (2015). Denosumab in treatment-naïve and pre-treated with zoledronic acid postmenopausal women with low bone mass: Effect on bone mineral density and bone turnover markers. Metabolism: Clinical and Experimental, 64(10), 1291-7. https://doi.org/10.1016/j.metabol.2015.06.018
Anastasilakis AD, et al. Denosumab in Treatment-naïve and Pre-treated With Zoledronic Acid Postmenopausal Women With Low Bone Mass: Effect On Bone Mineral Density and Bone Turnover Markers. Metabolism. 2015;64(10):1291-7. PubMed PMID: 26198440.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Denosumab in treatment-naïve and pre-treated with zoledronic acid postmenopausal women with low bone mass: Effect on bone mineral density and bone turnover markers. AU - Anastasilakis,Athanasios D, AU - Polyzos,Stergios A, AU - Efstathiadou,Zoe A, AU - Savvidis,Matthaios, AU - Sakellariou,Grigorios T, AU - Papatheodorou,Athanasios, AU - Kokkoris,Panagiotis, AU - Makras,Polyzois, Y1 - 2015/06/27/ PY - 2015/01/23/received PY - 2015/06/22/revised PY - 2015/06/24/accepted PY - 2015/7/23/entrez PY - 2015/7/23/pubmed PY - 2015/12/30/medline KW - Bone markers KW - Bone mineral density KW - Denosumab KW - RANKL KW - Zoledronic acid SP - 1291 EP - 7 JF - Metabolism: clinical and experimental JO - Metabolism VL - 64 IS - 10 N2 - PURPOSE: To compare denosumab-induced changes in lumbar spine (LS) and femoral neck (FN) bone mineral density (BMD), bone markers and free soluble receptor activator of nuclear factor kappaB ligand (sRANKL) between treatment naïve postmenopausal women with low bone mass (naïve group) and those who were previously treated with a single zoledronic acid infusion (post-Zol group). PROCEDURES: Procollagen type 1N-terminal propeptide (P1NP), C-terminal cross-linking telopeptide of type 1 collagen (CTx) and sRANKL levels were measured in serum samples obtained at baseline and 3, 6 and 12months after denosumab initiation. LS and FN BMD were measured at baseline and 12months. RESULTS: LS and FN BMD increased significantly in both naïve and post-Zol group (p<0.001 and p=0.025 vs. p<0.001 and p=0.017, respectively). Despite the higher P1NP and CTx levels in naïve patients at baseline (both p<0.001), denosumab caused comparable decreases in both groups at month 3, which returned to post-Zol group baseline levels at month 6 and 12 in all patients. Similarly, sRANKL levels decreased significantly at month 3 in both groups and returned to baseline levels at months 6 and 12. CONCLUSIONS: In patients previously treated with zoledronic acid, sequential denosumab treatment is effective in terms of BMD increases and bone turnover suppression. Despite the lower baseline levels in patients pre-treated with zoledronic acid, bone markers are similarly decreased in both groups following denosumab administration and maintain their reversibility. Denosumab reversibly suppresses endogenous free sRANKL levels in both naïve and zoledronic acid pre-treated patients. SN - 1532-8600 UR - https://www.unboundmedicine.com/medline/citation/26198440/Denosumab_in_treatment_naïve_and_pre_treated_with_zoledronic_acid_postmenopausal_women_with_low_bone_mass:_Effect_on_bone_mineral_density_and_bone_turnover_markers_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0026-0495(15)00179-1 DB - PRIME DP - Unbound Medicine ER -