Clinical Effects of a 6-Month Treatment Course of Ibandronate, Vitamin D, and Calcium in Postmenopausal Women from Central America: Results of a Multinational, Prospective Pilot Study

Abstract

Background/Aims: To explore the effects of ibandronate plus a supplementation of vitamin D and calcium on bone mineral density (BMD) and health-related quality of life (HRQoL) in a sample of postmenopausal women from Central America. Secondarily, factors related to the magnitude of improvements in BMD after treatment were investigated. Methods: Postmenopausal women with idiopathic osteoporosis or at risk of developing it, who were going to start treatment with ibandronate 150 mg once a month plus daily supplementation with vitamin D 400-800 IU and calcium 500-1,000 mg, were followed up for 6 months. BMD, HRQoL (mini-Osteoporosis Quality of Life Questionnaire), and treatment adherence (Morisky scale) were studied before and after treatment. Results: Four hundred and twenty-five women were assessed at baseline, and 308 (72%) were reassessed at month 6. Lumbar spine, proximal femur, and hip BMD increased by 3.35 ± 0.75, 1.88 ± 0.50, and 2.75 ± 0.32%, respectively (p < 0.001 for all). HRQoL total score and emotional functioning, symptoms, physical function, and leisure subscores improved by 26-49% (p < 0.01 in all cases). Lower body mass index, younger age at menopause, use of corticoids, and higher adherence were significantly and independently associated with a greater improvement in lumbar spine BMD (logistic regression). Conclusion: Improvements in BMD and HRQoL after ibandronate, vitamin D, and calcium were observed in patients from Central America, which should be confirmed by double-blind, randomized, controlled trials. Lack of adherence to ibandronate was related to worse outcomes, thus highlighting the need for work on this issue with patients on treatment.