Horm Metab Res
DOI: 10.1055/a-2371-1642
Original Article: Endocrine Care

Efficacy of Recombinant Human Parathyroid Hormone 1–34 and Vitamin K2 Combination Therapy in Postmenopausal Osteoporosis

Zhuo Zhang
1   Surgery of Spine and Bone Tumors, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, China
,
Kun Xia
1   Surgery of Spine and Bone Tumors, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, China
,
Wentao Gong
1   Surgery of Spine and Bone Tumors, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, China
,
Ruopeng Mai
1   Surgery of Spine and Bone Tumors, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, China
,
Peng Liu
1   Surgery of Spine and Bone Tumors, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, China
,
Zhaogang Lu
2   Department of Clinical Pharmacy, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, China
› Institutsangaben
Funding Information Hospital training to revitalize research projects | 201905

Abstract

This study aimed to assess the efficacy and safety of a combined recombinant human parathyroid hormone 1–34 [rhPTH (1–34)] and vitamin K2 therapy versus vitamin K2 alone in the treatment of postmenopausal osteoporosis. A total of 77 postmenopausal osteoporosis patients were randomly divided into two groups. Patients in one group received vitamin K2 alone, while patients in the other group received a combination of rhPTH (1–34) and vitamin K2. Bone mineral density (BMD), electrolyte levels, pain scores, bone metabolism levels, and adverse drug reactions were compared pre- and post-treatment. Both two treatments improved BMD, blood calcium concentrations, pain scores, and increased osteocalcin and osteoprotegerin levels. Notably, the combined rhPTH (1–34) and vitamin K2 treatment demonstrated superior efficacy in improving BMD and bone metabolism markers. Furthermore, there was no significant difference in the incidence of adverse reactions between the two groups, indicating the safety of the combined treatment. In summary, the combined therapy of rhPTH (1–34) and vitamin K2 exhibited more potent efficacy in the treatment of postmenopausal osteoporosis, more effectively enhancing BMD and bone metabolism markers than vitamin K2 alone, without a significant increase in adverse reactions.

Supplementary Material



Publikationsverlauf

Eingereicht: 10. April 2024

Angenommen nach Revision: 20. Juli 2024

Artikel online veröffentlicht:
28. August 2024

© 2024. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Yan G, Huang Y, Cao H. et al. Association of breastfeeding and postmenopausal osteoporosis in Chinese women: a community-based retrospective study. BMC Womens Health 2019; 19: 110
  • 2 Choi MH, Yang JH, Seo JS. et al. Prevalence and diagnosis experience of osteoporosis in postmenopausal women over 50: focusing on socioeconomic factors. PLoS One 2021; 16: e0248020
  • 3 Zhang X, Wang Z, Zhang D. et al. The prevalence and treatment rate trends of osteoporosis in postmenopausal women. PLoS One 2023; 18: e0290289
  • 4 Fischer V, Haffner-Luntzer M. Interaction between bone and immune cells: Implications for postmenopausal osteoporosis. Semin Cell Dev Biol 2022; 123: 14-21
  • 5 Sharma A, Sharma L, Saini RV. et al. Pinus roxburghii alleviates bone porosity and loss in postmenopausal osteoporosis by regulating estrogen, calcium homeostasis and receptor activator of nuclear factor-κB, osteoprotegerin, cathepsin bone markers. J Pharm Pharmacol 2021; 73: 901-915
  • 6 Chlebek C, Moore JA, Ross FP. et al. Molecular identification of spatially distinct anabolic responses to mechanical loading in murine cortical bone. J Bone Miner Res 2022; 37: 2277-2287
  • 7 Li W, Zhang S, Liu J. et al. Vitamin K2 stimulates MC3T3‑E1 osteoblast differentiation and mineralization through autophagy induction. Mol Med Rep 2019; 19: 3676-3684
  • 8 Ma ML, Ma ZJ, He YL. et al. Efficacy of vitamin K2 in the prevention and treatment of postmenopausal osteoporosis: a systematic review and meta-analysis of randomized controlled trials. Front Public Health 2022; 10: 979649
  • 9 Zhang Y, Liu Z, Duan L. et al. Effect of low-dose vitamin K2 supplementation on bone mineral density in middle-aged and elderly Chinese: a randomized controlled study. Calcif Tissue Int 2020; 106: 476-485
  • 10 Emaus N, Gjesdal CG, Almås B. et al. Vitamin K2 supplementation does not influence bone loss in early menopausal women: a randomised double-blind placebo-controlled trial. Osteoporos Int 2010; 21: 1731-1740
  • 11 Rønn SH, Harsløf T, Oei L. et al. The effect of vitamin MK-7 on bone mineral density and microarchitecture in postmenopausal women with osteopenia, a 3-year randomized, placebo-controlled clinical trial. Osteoporos Int 2021; 32: 185-191
  • 12 Moore AE, Dulnoan D, Voong K. et al. The additive effect of vitamin K supplementation and bisphosphonate on fracture risk in post-menopausal osteoporosis: a randomised placebo controlled trial. Arch Osteoporos 2023; 18: 83
  • 13 Gou P, Zhao Z, Yu C. et al. Efficacy of recombinant human parathyroid hormone versus vertebral augmentation procedure on patients with acute osteoporotic vertebral compression fracture. Orthop Surg 2022; 14: 2510-2518
  • 14 Leali PT, Balsano M, Maestretti G. et al. Efficacy of teriparatide vs neridronate in adults with osteogenesis imperfecta type I: a prospective randomized international clinical study. Clin Cases Miner Bone Metab 2017; 14: 153-156
  • 15 Kothari R, Kumar V, Jena R. et al. Modes of degradation and impurity characterization in rhPTH (1-34) during stability studies. PDA J Pharm Sci Rechnol 2011; 65: 348-362
  • 16 Neer RM, Arnaud CD, Zanchetta JR. et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 2001; 344: 1434-1441
  • 17 Deng J, Feng Z, Li Y. et al. Efficacy and safety of recombinant human parathyroid hormone (1-34) are similar to those of alendronate in the treatment of postmenopausal osteoporosis. Medicine (Baltimore) 2018; 97: e13341
  • 18 Meier C, Lamy O, Krieg M. et al. The role of teriparatide in sequential and combination therapy of osteoporosis. Swiss medical weekly 2014; 144: w13952
  • 19 Kanis JA, Melton LJ, Christiansen C. et al. The diagnosis of osteoporosis. J Bone Miner Res 1994; 9: 1137-1141
  • 20 Kužma M, Vaňuga P, Ságová I. et al. Vertebral fractures occur despite control of acromegaly and are predicted by cortical volumetric bone mineral density. J Clin Endocrinol Metab 2021; 106: e5088-e5096
  • 21 Yang JJ, Zhang XM. Clinical efficacy of glucosamine plus sodium hyaluronate for osteoporosis complicated by knee osteoarthritis and its influence on joint function and bone metabolic markers. Comput Math Methods Med 2022; 2022; 6078254
  • 22 Li F, Zhu L, Geng Y. et al. Effect of hip replacement surgery on clinical efficacy, VAS score and Harris hip score in patients with femoral head necrosis. Am J Transl Res 2021; 13: 3851-3855
  • 23 Kužma M, Jackuliak P, Killinger Z. et al. Parathyroid hormone-related changes of bone structure. Physiol Res 2021; 70: S3-S11
  • 24 Satterwhite J, Heathman M, Miller PD. et al. Pharmacokinetics of teriparatide (rhPTH[1-34]) and calcium pharmacodynamics in postmenopausal women with osteoporosis. Calcif Tissue Int 2010; 87: 485-492
  • 25 Ebeling PR, Russell RG. Teriparatide (rhPTH 1-34) for the treatment of osteoporosis. Int J Clin Pract 2003; 57: 710-718
  • 26 Zhou M, Han S, Zhang W. et al. Efficacy and safety of vitamin K2 for postmenopausal women with osteoporosis at a long-term follow-up: meta-analysis and systematic review. J Bone Miner Metab 2022; 40: 763-772
  • 27 Abdel Aziz DM, Saleh HA, Taha NM. et al. Relation between circulating vitamin k2 level and osteoporosis in post-menopausal women. AQJM Int J Med. 2021 114. hcab116. 002
  • 28 Solmaz I, Ozdemir MA, Unal E. et al. Effect of vitamin K2 and vitamin D3 on bone mineral density in children with acute lymphoblastic leukemia: a prospective cohort study. J Pediatr Endocrinol Metab 2021; 34: 441-447
  • 29 Ying M, Mao J, Sheng L. et al. Biomarkers for prostate cancer bone metastasis detection and prediction. J Pers Med 2023; 13: 705
  • 30 Subedi L, Pandey P, Kang SH. et al. Enhanced oral absorption of teriparatide with therapeutic potential for management of osteoporosis. J Control Release 2022; 349: 502-519