The effect of OsteoStrong compared to dynamic multicomponent exercise on bone strength in older women: the BONEMORE non-inferiority randomized controlled trial.

UNLABELLED: The efficacy of OsteoStrong® (OS) on bone strength is limited, and how it compares to dynamic multicomponent exercise (DME) is unknown. In this randomized controlled trial, the effect of OS on bone material strength index (BMSi) in older women was non-inferior to that of DME. No significant interaction between treatment and time was observed in any measured outcomes, indicating no meaningful difference between the intervention groups. Although the OsteoStrong® intervention met the pre-specified non-inferiority margin compared to the DME group, the lack of efficacy of the DME intervention on BMSi limits the interpretation of this finding.

PURPOSE: The aim of this study was to investigate whether the effect of using OS was non-inferior to DME for the primary outcome of BMSi in older women.

METHODS

Women aged 65-79 years with osteopenia or osteoporosis were randomized to 9 months of once-weekly OS (20 min) or twice-weekly DME (60 min/session). A total of 194 women (OS, 97; DME, 97), median age 70 years, participated in the trial. The primary outcome was BMSi measured with impact microindentation at the tibia. A pre-specified non-inferiority margin of BMSi -5.2 was applied to determine whether the intervention's efficacy was not clinically worse than the comparator within an acceptable threshold. The secondary outcomes were bone mineral density (BMD) and bone markers (S-CTX, S-P1NP, S-BALP, and S-sclerostin).

RESULTS

At the 9-month follow-up, there were no significant differences between the groups in any of the outcomes. The mean between‑group difference in BMSi was 1.16, with a 95% confidence interval ranging from - 1.51 to 3.82. Since the lower limit of the confidence interval (- 1.51) did not cross the predefined non‑inferiority margin of - 5.2, non‑inferiority was established. There was a significant increase in BMSi by 2.9% in the OS group (from 73.9 ± 9.5 to 76 ± 9.4, p = 0.026), and lumbar spine BMD by 0.8% in the DME group (from 0.866 g/cm2 ± 0.13 to 0.872 g/cm2 ± 0.13, p = 0.016). Changes in femoral neck BMD were not significant. There were no significant within- or between-group differences in any of the bone markers at 3 and 9 months.

CONCLUSIONS

Based on these findings, the effect of OsteoStrong® on BMSi in older women was non-inferior to that of dynamic multicomponent exercise. No significant interaction between treatment and time was observed in any measured outcomes, indicating no meaningful difference between the intervention groups. Although the OsteoStrong® intervention met the pre-specified non-inferiority margin compared to the DME group, the lack of efficacy of the DME intervention on BMSi limits the interpretation of this finding.