Evaluation of the fracture prevention effects of teriparatide and alendronate in patients with frailty: a sub-analysis of the Japanese osteoporosis intervention trial-05.

Abstract

Introduction: The fracture prevention effects of teriparatide (TPTD) and alendronate (ALN) were evaluated in frail patients using data from the JOINT-05 trial. In addition, predictors of adherence-related treatment discontinuation were evaluated for TPTD and ALN.

Materials and methods: Japanese women aged ≥ 75 years with primary osteoporosis and high fracture risk were randomized to either sequential therapy (TPTD for 72 weeks followed by ALN for 48 weeks) or ALN monotherapy for 120 weeks. Cognitive frailty was defined as an MMSE score ≤ 27, and physical frailty as requiring support or nursing care. Vertebral, non-vertebral, and all fractures were assessed. Adherence-related discontinuations were identified, and baseline predictors were analyzed using multiple regression to calculate odds ratios.

Results: A total of 514 patients with cognitive frailty (254 with TPTD, 260 with ALN) and 204 patients with physical frailty (109 with TPTD, 95 with ALN) were identified. In patients with cognitive frailty, vertebral fracture incidence tended to be lower with TPTD (rate ratio 0.72), but not significantly. In patients with physical frailty, the incidence was significantly lower with TPTD (rate ratio 0.50, p < 0.01). Dyslipidemia and serum calcium levels were significant predictors of TPTD discontinuation, whereas cognitive impairment and dyslipidemia were predictors for ALN discontinuation.

Conclusion: In patients with physical frailty, TPTD reduced vertebral fractures significantly more than ALN. However, in cases with cognitive impairment, the results of the JOINT-05 study may not necessarily apply. Assessing the presence of dyslipidemia and cognitive decline may be useful for predicting adherence-related discontinuation.

Trial registration: jRCTs031180235 and UMIN000015573, March 12, 2019.