Anti-resorptive and anabolic therapies improve Falls Risk Assessment Score (FRAS) in postmenopausal women with type 2 diabetes mellitus.

UNLABELLED: Zoledronate, denosumab and teriparatide improve Falls Risk Assessment Score (FRAS) and reduce the number of participants experiencing falls over the last 12 months when administered over a period of 72 weeks to postmenopausal women with type 2 diabetes mellitus at a high risk of fragility fractures.

PURPOSE: Type 2 diabetes mellitus (T2D) increases the risk of falls, which also exacerbates the risk of fragility fractures. We aimed at exploring the effects of anti-osteoporotic therapies (zoledronate, denosumab or teriparatide) on the risk of falls in postmenopausal women with T2D.

METHODS

We performed an exploratory analysis of a randomized clinical pilot trial primarily designed to compare the efficacy of zoledronate, denosumab, or teriparatide in T2D (CTRI/2022/02/039978). Postmenopausal women (≥ 50 years) with T2D and high risk of fragility fractures were randomized to receive zoledronate (5 mg annually), denosumab (60 mg bi-annually), teriparatide (20 mcg daily) or only standard of care (calcium and cholecalciferol) for 72 weeks. The risk of falls was assessed using FRAS (Falls Risk Assessment Score) questionnaire at baseline and 72 weeks.

RESULTS

129 postmenopausal women were randomized to one of the four treatment arms (mean age 64.2 ± 6.7 years). The baseline characteristics including FRAS were matched between four arms. At 72 weeks, all three interventions led to a significant reduction in FRAS (p = 0.002 for teriparatide, p = 0.004 for zoledronate, p = 0.004 for denosumab). No improvement was observed in control arm (p = 0.875). The number of participants experiencing more than one fall in last 12 months reduced in teriparatide, zoledronate and denosumab arms, while it increased in control arm (between-group p = 0.033). Glycemic status, renal function, calcium and vitamin D status either remained unchanged over 72 weeks or did not correlate with change in FRAS.

CONCLUSIONS

Zoledronate, denosumab and teriparatide reduce the risk of falls that might contribute to their anti-fracture efficacy.