Fig 1.
Flowchart of the clinical trial.
Fig 2.
Moderate static magnetic field (MMF) device in clinical trial.
(A) Schematic diagram of magnet size and array layout of MMF device. (B) Magnetic packaging structure. (C) The magnetic field distribution of vertebrae during MMF exposure was simulated using ANSYS software. (D, E) Magnetic field distribution at 5 mm (D) and 90 mm (E) above the magnet were measured by MIST magnetic field space-time imaging system. (F) Diagram of the body-worn MMF device.
Fig 3.
Moderate static magnetic field (MMF) exposure device for mice.
(A) The diagram of magnetic plate that provide MMF. (B) Relative position of mice during exposure to MMF. (C) Magnetic field distribution in the mouse exposure area, 1 cm above the magnetic plates. (D) Direction and distribution of magnetic induction lines in magnetic exposure systems.
Fig 4.
Effects of MMF exposure on bone structure and mechanical properties in OVX mice.
(A) Three-dimensional images of cortical architecture in femoral mid-shaft by micro-CT scanning. (B) Three-dimensional images of trabecular architecture in distal femur by micro-CT scanning. (C) Structural parameters of cortical bone, including Ct.Th, Ct.Ar, Ct.Ar/Tt.Ar, Ct.Po, and TMD. (D) Structural parameters of trabecular bone, including BV/TV, Tb.N, Tb.Th, Tb.Sp, and BMD. (E) Mechanical properties of the tibia in mice were detected through the three-point bending test, including stiffness, ultimate load, ultimate stress, elastic modulus, and bending energy absorption. n = 6. *P < 0.05, **P < 0.01, ***P < 0.001.
Fig 5.
Effects of MMF exposure on bone remodeling in OVX mice.
(A) H&E staining of cortical bone in femoral mid-shaft and trabecular bone in distal femur (Scale bar = 100 μm). Black arrows mark osteoblasts. (B) The osteoblast number per bone surface (N.Ob/BS) in cortical bone. (C) The osteoblast number per bone surface (N.Ob/BS) in trabecular bone. Serum bone formation markers, OCN (D) and P1NP (E) were detected using the commercial ELISA kits. (F) TRAP staining of cortical bone in femoral mid-shaft and trabecular bone on distal femur (Scale bar = 100 μm). Osteoclast number per bone surface (N.Oc/BS) (G) and osteoclast surface per bone surface (Oc.S/BS) (H) in cortical bone. osteoclast number per bone surface (N.Oc/BS) (I) and osteoclast surface per bone surface (Oc.S/BS) (J) in trabecular bone. (K)Serum bone resorption marker, β-CTX was detected using the commercial ELISA kit. n = 6. *P < 0.05, **P < 0.01, ***P < 0.001.
Table 1.
Participants baseline characteristics.
Fig 6.
Mean percentage change in aBMD of the lumbar spine (A), total hip (B), and femoral neck (C) after 90 days treatment in clinical trial. aBMD = areal bone mineral density.
Fig 7.
Change in bone turnover markers and VAS of low back pain after 90 days treatment in clinical trial.
(A-C) Mean percentage change in serum concentrations of bone formation makers, OCN (A) and P1NP (B), as well as bone resorption marker β-CTX (C). (D) Mean change in VAS of low back pain after 90 days treatment in clinical trial. OCN = osteocalcin. P1NP = N-terminal propeptide of type 1 procollagen. β-CTX = beta-isomer of C-Terminal Telopeptide of Type I Collagen. *P < 0.05, **P < 0.01.