Feasibility, safety and efficacy of OsteoStrong® in postmenopausal women with low bone mineral density: A pilot study

OsteoStrong® is a brief, near-isometric loading exercise modality that targets bone health improvements by applying forces at relevant anatomical sites using specific equipment during ∼10-min, once weekly sessions. Evidence on adherence, safety and effectiveness is limited. In this single-arm pilot study, we determined the feasibility of 8 months of OsteoStrong® for postmenopausal women with low BMD, and measured changes in bone density, microarchitecture and strength, physical function and body composition. Forty-four postmenopausal women with low BMD (DXA-determined T-score < -1.0 but > - 3.0 at total hip and/or lumbar spine) attended supervised, once-weekly 10-15-min sessions at an OsteoStrong® clinic for 8 months. We calculated 8-month changes in areal BMD (aBMD), trabecular bone scores (TBS), HR-pQCT-determined volumetric BMD (vBMD) and bone microarchitecture and strength, as well as physical function and body composition. Thirty-eight women aged 61.2 ± 5.5 years completed the study. Two adverse events suspected to be intervention-related were recorded. Adherence was 83 ± 28 % overall and 93 ± 9 % in those who completed the study. At 8 months, there were no changes in total hip, femoral neck, and lumbar spine aBMD (all P > 0.05), while TBS decreased (P < 0.05). At the distal radius, total, trabecular and cortical vBMD and cortical thickness decreased (mean change: -0.007 mm [95 %CI: -0.012, -0.002]). At the distal tibia, cortical vBMD decreased and trabecular separation increased (mean change: 0.007 mm [95 %CI: 0.001, 0.012]). Chair stand time (mean change: -0.8 s [95 %CI: -1.2, -0.5]) and stair climb time (mean change: -0.1 s [95 %CI: -0.2, -0.002]) decreased, while SPPB scores increased (mean change: 0.2 [95 %CI: 0.03, 0.38]). There were no changes in other bone, physical function or body composition outcomes. These findings suggest that 8 months of OsteoStrong® does not significantly improve bone density, microarchitecture, or strength in healthy postmenopausal women with low BMD, despite good adherence and safety. Australian New Zealand Clinical Trials Registration: ACTRN12620000224921p.