An intravenous (I.V.) injection of the new osteoporosis drug called Bonviva (ibandronate), administered every two or three months, has been shown to be highly effective and well tolerated over two years. These results, from the DIVA study, were presented at the annual meeting of the American College of Rheumatology in San Diego, USA and suggest that the I.V. formulation of ibandronate may offer an effective alternative for a select group of women with postmenopausal osteoporosis who are unable to take oral bisphosphonates, a release from Roche stated here.
Pierre Delmas, Professor of Medicine and Rheumatology and Director of the INSERM Research Unit in Lyon commented on the implication of these results: "These findings are very exciting, as they confirm Bonviva I.V. injection has the potential to bring the long term bone strengthening benefits of bisphosphonate therapy to those women who are unable to stay upright for the required length of time or have another medical condition which means they are unable to take an oral bisphosphonate. In addition, the clinician can be certain that the patient receives a therapeutic dose as part of an ongoing treatment regimen."
DIVA (Dosing IntraVenous Administration) studied the efficacy, safety and tolerability of two novel I.V. regimens - 2mg every two months or 3mg every three months. When compared to the once- daily oral formulation of ibandronate (which in previous studies has been shown to reduce the risk of vertebral fracture in women with postmenopausal osteoporosis by 62% over three years) both I.V. ibandronate regimens-Demonstrated significantly greater increases in bone mineral density (BMD) at the lumbar spine; Showed consistently greater increases in BMD at all hip sites measured;
Were well-tolerated, with similar overall rates of adverse events.
Regulatory files have been submitted to both the US and the European Union Health Authorities.
Both the monthly oral and I.V. formulations represent important advances in the treatment of osteoporosis, as many patients discontinue daily and weekly osteoporosis therapy for convenience reasons. This may help to explain why more than half the patients with postmenopausal osteoporosis stop taking their once-daily or once-weekly bisphosphonate treatment within a year, foregoing the bone-building benefits these drugs can only provide over time, the release added.
DIVA (Dosing IntraVenous Administration) is a multinational, randomised, double-blind, active control multi-centre study in 1,395 women with postmenopausal osteoporosis aged between 55 and 80 years of age. DIVA aims to compare the safety, efficacy and tolerability of the approved oral daily ibandronate 2.5mg regimen with two novel I.V. regimens: 2mg every two months and 3mg every three months, with lumbar spine BMD at one year as the primary endpoint.
In December 2001, F. Hoffmann-La Roche Ltd (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan.