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. 2019 Mar;5(1):11-18.
doi: 10.1016/j.afos.2019.02.002. Epub 2019 Mar 14.

Effectiveness of monthly intravenous ibandronate injections in a real-world setting: Subgroup analysis of a postmarketing observational study

Yasuhiro Takeuchi  1 , Junko Hashimoto  2 , Hiroyuki Kakihata  3 , Yousuke Nishida  3 , Michiko Kumagai  3 , Chiemi Yamagiwa  3
Affiliations

Effectiveness of monthly intravenous ibandronate injections in a real-world setting: Subgroup analysis of a postmarketing observational study

Yasuhiro Takeuchi et al. Osteoporos Sarcopenia. 2019 Mar.

Abstract

Objectives: The favorable safety and consistent effectiveness of monthly intravenous (IV) ibandronate injections was demonstrated in a prospective, postmarketing, observational study in Japanese patients with osteoporosis. Here, we present subgroup analyses from the study.

Methods: Lumbar spine (L2-4) bone mineral density (BMD) gains were assessed in the following subgroups: aged <75 or ≥75 years, absence or presence of vertebral fractures, previous bisphosphonate (BP) treatment, and concomitant versus naïve osteoporosis drug treatment. The cumulative incidence of fractures and relative change in bone turnover markers were also examined.

Results: Of 1062 enrolled patients, 1025 received monthly IV ibandronate 1 mg and were assessed for 12 months. BMD gains with ibandronate were comparable, irrespective of older age or prevalent fractures. Overall, 515 patients (50.2%) had previously received osteoporosis treatment; of these, 166 (16.1%) received other BPs. Mean BMD changes were 3.69% (95% confidence interval [CI], 0.89%-6.50%) in patients previously treated with other BPs, and 4.26% (95% CI, 2.88%-5.64%) in patients who had not received prior osteoporosis treatment. Among the 510 patients (49.7%) concomitantly prescribed active vitamin D drugs, mean BMD changes were 5.74% (95% CI, 2.53%-8.95%) with eldecalcitol versus 3.54% (95% CI, 1.98%-5.10%) with ibandronate alone. The lowest fracture incidence was observed with the combination of ibandronate and eldecalcitol, but differences between the subgroups were not statistically significant.

Conclusions: Monthly IV ibandronate demonstrated comparable BMD gains in the patient subgroups analyzed. Concomitant use of ibandronate with eldecalcitol showed a trend of higher BMD gains and lower fracture incidence than ibandronate alone.

Keywords: Eldecalcitol; Ibandronate; Japan; Observational study; Osteoporosis.

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Figures

Fig. 1
Fig. 1
Mean relative change in lumbar spine (L2–4) bone mineral density (BMD) from baseline to 12 months (with 95% confidence interval) in: (A) patients aged <75 versus ≥75 years; and (B) patients with versus without prevalent vertebral fractures.
Fig. 2
Fig. 2
Mean relative change in: (A) lumbar spine (L2–4) bone mineral density (BMD) and (B) tartrate-resistant acid phosphatase-5b (TRACP-5b) levels from baseline to 12 months (with 95% confidence intervals) in patient subgroups receiving no prior treatment, other bisphosphonates, or other osteoporosis treatment.
Fig. 3
Fig. 3
Mean relative change in: (A) lumbar spine (L2–4) bone mineral density (BMD) and (B) tartrate-resistant acid phosphatase-5b (TRACP-5b) levels from baseline to 12 months (with 95% confidence intervals) in patient subgroups receiving no concomitant vitamin D, concomitant eldecalcitol, or concomitant alfacalcidol or calcitriol.
Fig. 4
Fig. 4
Nonvertebral fracture incidence according to vitamin D drug treatment: (A) ibandronate alone versus ibandronate with concomitant eldecalcitol; (B) concomitant alfacalcidol or calcitriol versus concomitant eldecalcitol.
Fig. 5
Fig. 5
Clinical fracture incidence according to vitamin D drug treatment: (A) ibandronate alone versus ibandronate with concomitant eldecalcitol; (B) concomitant alfacalcidol or calcitriol versus concomitant eldecalcitol.
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