TRIP

Ibandronic acid (Bonviva)

Scottish Medicines Consortium, 2006

Roche/GSK New formulation 6 January 2006 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland.
The advice is summarised as follows: ADVICE: following a full submission Ibandronic acid (Bonviva _ ) is accepted for use within NHS Scotland for the treatment of osteoporosis in postmenopausal women in order to reduce the risk of vertebral fractures.
Ibandronic acid 150mg monthly is superior to daily ibandronic acid in terms of lumbar spine bone mineral density at 1 year.
Compared with placebo, daily administration of ibandronic acid results in a relative risk reduction for vertebral fractures of 62%.
Unlike some other bisphosphonates, efficacy in reducing femoral neck fractures (and other non-vertebral fractures) has not been established.
Indication Treatment of osteoporosis in postmenopausal women in order to reduce the risk of vertebral fractures.
It should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day or any other oral medicinal products or supplementation (including calcium).
Comparator medications Alendronate, risedronate sodium, raloxifene, disodium etidronate, calcitonin and teriparatide are included in the Scottish Intercollegiate Guidelines Network (SIGN) guideline, Management of Osteoporosis and the National Institute of Health and Clinical Excellence (NICE) appraisal, Bisphosphonates, selective oestrogen receptor modulators and parathyroid hormone for the secondary prevention of osteoporotic fragility fractures in postmenopausal women.
Summary of evidence on comparative efficacy Bisphosphonates act by reducing osteoclast-mediated bone resorption, which results in a decrease in bone turnover, an increase in bone mineral density (BMD) and a reduction in fracture risk.
Two phase III randomised double-blind parallel group studies have been conducted with ibandronic acid; one comparing placebo, daily administration and an intermittent administration regimen and the second study comparing daily administration with three different monthly regimens.
The first study recruited women aged between 55 and 80 years, who were post-menopausal for = 5 years with a lumbar BMD T-score between -2 and -5 in at least one vertebra and 1-4 prevalent vertebral fractures.