Moderate Static Magnetic Fields Prevent Estrogen Deficiency-Induced Bone Loss: Evidence from Ovariectomized Mouse Model and Small Sample Size Randomized Controlled Clinical Trial

Abstract

Background Postmenopausal osteoporosis (PMOP) is the most common type of osteoporosis. Numerous studies have shown that static magnetic fields (SMFs) can inhibit bone loss by regulating bone remodeling. However, there are currently no clinical studies on the treatment of osteoporosis with SMFs. This study aims to investigate the clinical therapeutic effects of moderate static magnetic fields (MMFs) on PMOP. Methods In this paper, we constructed MMF device using neodymium-iron-boron (NdFeB) materials. At the animal level, the effect of MMF exposure for 8 weeks on estrogen deficiency-induced bone loss was investigated by evaluating bone microstructure, mechanical properties, and bone conversion using ovariectomized (OVX) mice. Clinically, a single-blind randomized controlled study in patients with PMOP was designed. PMOP patients aged 55-70 years were recruited and randomized into the control and MMF treatment groups. Clinical assessments of bone mineral density (BMD), bone turnover markers (BTMs) and VAS scores were performed at baseline and day 90, respectively. Results The results showed that MMF exposure significantly improved BMD, bone mineral content (BMC), bone microarchitecture and bone strength in OVX mice. For bone turnover, MMF increased the number of osteoblasts on the bone surface of OVX mice as well as the level of serum bone formation marker P1NP, while decreasing the number of osteoclasts and the level of serum bone resorption marker β-CTX. The clinical trial’s results showed that MMF treatment had a positive effect on the improvement of BMD in the lumbar spine and increased serum P1NP levels while decreased β-CTX levels. In addition, MMF treatment decreased participants' VAS scores for low back pain. Conclusions The results of both animal and clinical studies demonstrated that MMF treatment improved bone turnover and have a positive effect on BMD improvement, as well as alleviated low back pain in PMOP patients. This study will promote the translational research and clinical application of SMF treatment for osteoporosis.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ChiCTR2100048604

Clinical Protocols

https://www.chictr.org.cn/showproj.html?proj=129823

Funding Statement

The author(s) received no specific funding for this work.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This clinical trial was performed in accordance with the approved institutional ethical protocol (Ethical Review of People's Hospital of Longhua [2021] No.106)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

All relevant data are within the manuscript and its Supporting Information files.

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