Efficacy and Safety of Oral Weekly Ibandronate in the Treatment of Postmenopausal Osteoporosis

Abstract

Adherence to oral daily bisphosphonate regimens in postmenopausal osteoporosis is currently suboptimal. Less frequent dosing regimens are likely to improve patient adherence and thus, potentially, patient outcomes. A multicenter, randomized, double-blind, noninferiority study was conducted in 235 women (53-80 yr old; time since menopause >/==" BORDER="0"> 3 yr) with postmenopausal osteoporosis [lumbar spine (L1-L4) bone mineral density (BMD) T-score </= -2] to demonstrate the noninferiority of an oral weekly (20 mg) ibandronate regimen compared with an oral daily (2.5 mg) ibandronate regimen. All patients received daily calcium (500 mg) and vitamin D (400 IU). The primary analysis was the relative change in lumbar spine (L1-L4) BMD from baseline after 48 wk in the per- protocol population. Daily and weekly ibandronate significantly increased spinal BMD by 3.47 and 3.53%, respectively, and provided substantial and similar decreases in biochemical markers of bone turnover. In the primary analysis, noninferiority of the weekly regimen to the daily regimen was demonstrated, with the boundary of the one-sided confidence interval, -0.96%, within both the -1.65% prespecified margin and a more stringent margin of -1.10%. These results demonstrate that oral weekly ibandronate provides the same efficacy and safety as oral daily ibandronate in women with postmenopausal osteoporosis.

Treatment of postmenopausal osteoporosis in women: a systematic review

“…Five studies evaluated oral ibandronate, with two on the incidence of vertebral fractures and four on changes in lumbar spine BMD 20,21,22,23,24 . In relation to incidence of vertebral fractures, in the study comparing ibandronate 2.5mg to placebo, the treatment group showed a better response than the placebo group (p < 0.0001) 20 .…”

“…Three studies evaluated lumbar spine BMD in comparisons between different dose models, but without comparing to placebo 22,23,24 . The different monthly or weekly dose models were not inferior to the daily model.…”

Biophosphonates: adherence to therapy is a pledge of successful treatment for osteoporosis

“…Осо-бый интерес представляют исследования на животных, ко-торые показали, что терапевтическая эффективность ибан-дроната определяется кумулятивной дозой за определен-ный период, а не частотой назначения [15][16][17][18]. Затем был проведен ряд клинических исследований влияния различ-ных доз ибандроната на МПК, уровень биохимических маркеров, риск развития новых переломов и переноси-мость, продемонстрировавших высокую эффективность и безопасность препарата у человека [19,20]. Эквивалентная эффективность общей дозы независимо от режима введе-ния позволила назначать его прерывисто и людям.…”

The role of estrogen in bone growth and formation: changes at puberty

“…1,2 The risk of osteoporotic fracture depends on two factors: the biomechanical strength of bone and the forces applied to it. Bone mass, a measure of bone size and volumetric mineral density, is a determinant of bone strength.…”