Randomized crossover comparison of two teriparatide self-injection regimens for primary osteoporosis: Interim report (end of 52-week treatment) of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06).

Abstract

Introduction: Patient satisfaction with two teriparatide (TPTD) self-injection regimens [once-daily (1/D)-TPTD and twice-weekly (2/W)-TPTD] was compared in a randomized crossover study involving patients with osteoporosis at high fracture risk.

Materials and methods: Questionnaires evaluated overall satisfaction, satisfaction with treatment effectiveness, satisfaction with utility of the self-injection device, and preference for a particular injection regimen after crossover. Quality of life (QOL), visual analogue scale pain scores, and bone mineral density (BMD) were also analyzed. Safety was evaluated based on the incidence and severity of adverse events (AEs).

Results: The 1/D-TPTD and 2/W-TPTD groups comprised 180 (mean age: 75.9 ± 7.3 years) and 178 (75.4 ± 6.9 years) patients, respectively. After 26 weeks of treatment, the injection regimens were switched and treatment continued for another 26 weeks. Significantly higher persistence was observed in the 1/D-TPTD to 2/W-TPTD group (p = 0.032). No significant between-group differences in overall satisfaction scores or satisfaction with treatment were observed. Satisfaction with the utility of the injection device was significantly higher with the 2/W-TPTD regimen (p < 0.05); this regimen was preferred by 69.4% of patients after crossover (p < 0.001). A significant increase in BMD from baseline was observed at the lumbar vertebrae in both groups and at the hip area in the 1/D-TPTD to 2/W-TPTD group at 52 weeks (p < 0.05). Significant improvement in the QOL score was observed in both groups (p < 0.05). No serious AEs were reported.

Conclusion: Continuation of this study will further clarify patient satisfaction, treatment effects, and tolerability.