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Abstract

Background

Denosumab is an effective drug for treating postmenopausal osteoporosis (PMO), yet some patients experience inadequate pain relief and suboptimal rates of bone mineral density (BMD) increase. Warm acupuncture, a traditional Chinese therapy, shows potential in alleviating pain and improving bone metabolism. This study aimed to evaluate the efficacy and safety of warm acupuncture combined with denosumab versus denosumab alone for PMO.

Methods

A prospective, randomized, open-label, controlled design was employed. 120 eligible PMO patients were randomly assigned to the Combination group (n = 60, receiving denosumab + warm acupuncture) or the Control group (n = 60, receiving denosumab only). The treatment period was 6 months. The primary outcome was the percentage change in lumbar spine (L1-L4) BMD. Secondary outcomes included changes in Visual Analogue Scale (VAS) pain score, serum bone turnover markers (β-CTX, PINP), 36-Item Short Form Health Survey (SF-36) scores, and adverse events.

Results

After treatment, the percentage change in lumbar BMD was significantly greater in the Combination group (+8.32 ± 3.15%) than in the Control group (+5.21 ± 2.78%) (P < 0.001). The Combination group also showed superior improvement in VAS score reduction (−4.45 ± 1.25 vs. −2.88 ± 1.42, P < 0.001), greater decrease in serum β-CTX (−0.40 ± 0.12 ng/mL vs. −0.32 ± 0.11 ng/mL, P < 0.001), and better scores in several SF-36 domains (notably Bodily Pain and Physical Function) (P < 0.05). No serious adverse events occurred in either group. The Combination group reported three cases of mild local burns from moxibustion, and the Control group reported 2 cases of mild flu-like symptoms.

Conclusion

Warm acupuncture combined with denosumab more effectively increases lumbar spine BMD, alleviates bone pain, further inhibits bone resorption, and improves quality of life in PMO patients, with a favorable safety profile. Warm acupuncture may serve as a beneficial adjunctive therapy to denosumab for PMO.

Keywords

postmenopausal osteoporosis warm acupuncture denosumab bone mineral density pain randomized controlled trial

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References

Mao

(2025). Mechanisms and traditional Chinese medicine therapeutics for primary osteoporosis: An integrated perspective. Frontiers in Endocrinology, 16, 1638629. https://doi.org/10.3389/fendo.2025.1638629

Bhatnagar

Kekatpure

A. L.

(2022). Postmenopausal osteoporosis: A literature review. Cureus, 14(9), e29367. https://doi.org/10.7759/cureus.29367

Chen

P.-C.

Hayashi

M. A. F.

Oliveira

E. B.

Karpel

R. L.

(2012). DNA-interactive properties of crotamine, a cell-penetrating polypeptide and a potential drug carrier. PloS one, 7(11), e48913. https://doi.org/10.1371/journal.pone.0048913

Hanley

D. A.

Adachi

J. D.

Bell

Brown

(2012). Denosumab: Mechanism of action and clinical outcomes. International Journal of Clinical Practice, 66(12), 1139–1146. https://doi.org/10.1111/ijcp.12022

Chen

Qian

Y.-P.

(2024). Wnt/β-catenin signaling components and mechanisms in bone formation, homeostasis, and disease. Bone Research, 12(1), 39. https://doi.org/10.1038/s41413-024-00342-8

Lamy

Everts-Graber

Rodriguez

E. G.

(2025). Denosumab for osteoporosis treatment: When, how, for whom, and for how long. A pragmatical approach. Aging Clinical and Experimental Research, 37(1), 70. https://doi.org/10.1007/s40520-025-02991-z

Chen

Dong

Zhang

Yang

Zhang

Song

Zou

(2014). Influence of exercise on bone remodeling-related hormones and cytokines in ovariectomized rats: A model of postmenopausal osteoporosis. PloS one, 9(11), e112845. https://doi.org/10.1371/journal.pone.0112845

Guo

Gong

Zhang

Fan

Yao

Chen

Dou

Lin

Chen

Lyu

(2021). The anti-inflammatory actions and mechanisms of acupuncture from acupoint to target organs via neuro-immune regulation. Journal of Inflammation Research, 14, 7191–7224. https://doi.org/10.2147/JIR.S341581

Liu

Z. F.

Zhang

Liu

Wang

Y. Y.

Chen

Liu

E. Y.

Guo

J.-M.

Wang

Y.-H.

Weng

Z.-W.

Liu

C.-X.

C.-H.

Wang

X.-Y.

(2024). Effect of traditional Chinese non-pharmacological therapies on knee osteoarthritis: A narrative review of clinical application and mechanism. Orthopedic Research and Reviews, 16, 21–33. https://doi.org/10.2147/ORR.S442025

10.

Zhang

(2025). Research progress of diabetic osteoporosis: A comprehensive review. Frontiers in Endocrinology, 16, 1595228. https://doi.org/10.3389/fendo.2025.1595228

11.

Nakamura

Matsumoto

Sugimoto

Hosoi

Miki

Gorai

Yoshikawa

Tanaka

Sone

Nakano

Ito

Matsui

Yoneda

Takami

Watanabe

Osakabe

Shiraki

Fukunaga

(2014). Clinical trials express: Fracture risk reduction with denosumab in Japanese postmenopausal women and men with osteoporosis: Denosumab fracture intervention randomized placebo controlled trial (DIRECT). The Journal of Clinical Endocrinology & Metabolism, 99(7), 2599–2607. https://doi.org/10.1210/jc.2013-4175

12.

Narayanan

(2013). Denosumab: A comprehensive review. South Asian Journal of Cancer, 2(4), 272–277. https://doi.org/10.4103/2278-330X.119895

13.

Peng

C. H.

Yang

M. M.

Kok

S. H.

Woo

Y. K.

(1978). Endorphin release: A possible mechanism of acupuncture analgesia. Comparative Medicine East and West, 6(1), 57–60. https://doi.org/ 10.1142/s0147291778000083

14.

Ping

Quanwu

Wei

Miao

Zheling

Ming

Liang

Liguang

(2024). Identifying the effective combination of acupuncture and traditional Chinese medicinal herbs for postmenopausal osteoporosis therapy through studies of their molecular regulation of bone homeostasis. Journal of Traditional Chinese Medicine = Chung I tsa Chih Ying wen pan, 44(1), 212–219. https://doi.org/10.19852/j.cnki.jtcm.20230904.006

15.

Popov

V. L.

Poliakov

A. M.

Pakhaliuk

V. I.

(2023). In silico evaluation of the mechanical stimulation effect on the regenerative rehabilitation for the articular cartilage local defects. Frontiers in Medicine, 10, 1134786. https://doi.org/10.3389/fmed.2023.1134786

16.

Sapra

Dar

H. Y.

Bhardwaj

Pandey

Kumari

Azam

Upmanyu

Anwar

Shukla

Mishra

P. K.

Saini

Verma

Srivastava

R. K.

(2021). Lactobacillus rhamnosus attenuates bone loss and maintains bone health by skewing Treg-Th17 cell balance in Ovx mice. Scientific Reports, 11(1), 1807. https://doi.org/10.1038/s41598-020-80536-2

17.

Teng

Zhu

Tong

Chu

Sun

(2025). Efficacy and safety of acupuncture as an adjuvant therapy for osteoporosis: A systematic review and meta-analysis of randomized controlled trials. Frontiers in Endocrinology, 16, 1561344. https://doi.org/10.3389/fendo.2025.1561344

18.

Tian

Wang

Zhu

Chen

Zhang

Xia

Che

Zhao

Zhang

(2022). Acupuncture for osteoporosis: A review of its clinical and preclinical studies. Innovations in Acupuncture and Medicine, 15(5), 281–299. https://doi.org/10.1007/s11426-022-1378-4

19.

D. M.

Liu

Wang

Liu

Tian

Zhang

Cao

(2018). Effect of thunder-fire moxibustion on pain, quality of life, and tension of Multifidus in patients with primary osteoporosis: A randomized controlled trial. Medical Science Monitor: International Medical Journal of Experimental and Clinical Research, 24, 2937–2945. https://doi.org/10.12659/MSM.909725

20.

Yuan

Guo

Liu

Sun

Zhang

(2016). The efficacy of warm needle acupuncture on knee osteoarthritis: A systematic review and meta-analysis. Journal of Evidence-Based Medicine, 9(3), 136–144. https://doi.org/10.1371/journal.pone.0117146

21.

Zhang

(2025). Risk factors for secondary fractures in postmenopausal osteoporosis: A retrospective study. Medicine, 104(41), e44629. https://doi.org/10.1097/MD.0000000000044629

22.

Zhang

J.-m.

Chao

A.-j.

Cheng

Teng

D.-h.

J.-m.

Wang

B.-w.

Huo

Y.-n.

Mao

Zhang

Yang

Yan

S.-g.

Zhang

K.-q.

Zhao

X.-l.

Lin

Pei

Yuan

Dai

R.-c.

Chen

Zhang

Z.-l.

(2023). A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk. Acta Pharmacologica Sinica, 44(2), 446–453. https://doi.org/10.1038/s41401-022-00954-y

23.

Zhu

Chen

Masson

Y.-P.

(2024). Cell signaling and transcriptional regulation of osteoblast lineage commitment, differentiation, bone formation, and homeostasis. Cell Discovery, 10(1), 71. https://doi.org/10.1038/s41421-024-00689-6

24.

Zhu

Liu

Chen

Deng

Cai

(2024). Multifunctional injectable hydrogel system as a mild photothermal-assisted therapeutic platform for programmed regulation of inflammation and osteo-microenvironment for enhanced healing of diabetic bone defects in situ. Theranostics, 14(18), 7140–7198. https://doi.org/10.7150/thno.102779

Efficacy Analysis of Warm Acupuncture Combined with Denosumab in the Treatment of Postmenopausal Osteoporosis

Abstract

Background

Methods

Results

Conclusion

Keywords

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References