Roche/Glaxo osteoporosis drug proves effective in monthly dosage

The ibandronic acid drug, known as Boniva in the US and Bonviva in Europe, proved to be as effective in a once monthly oral dose formulation as in the approved once daily dose form over a two year period. The 150mg Boniva monthly regimen, approved in the US in March 2005, was prospectively demonstrated to be significantly better than the 2.5mg Boniva daily regimen in a trial of 1609 women with postmenopausal osteoporosis.

Daily Boniva, indicated for the treatment and prevention of osteoporosis in postmenopausal women, reduces bone turnover, increases bone mineral density and reduces the incidence of vertebral fractures. Although the monthly application of the drug is approved in the US, European authorities are still deliberating its marketing approval.

Lumbar spine bone mineral density increased in all groups treated with the drug, however, the 150mg regimen continued to be superior to daily Bonviva. These two year data also confirmed the good tolerability previously seen at one year with adverse incidents arising at a similar proportion between both groups.

The companies believe Boniva is the only bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than two months.

William Burns, CEO division Roche said: “These new data confirm the one year results presented in 2004 and further strengthen the evidence for the first monthly oral treatment for osteoporosis. Bonviva offers the proven efficacy of a bisphosphonate with the convenience of just 12 tablets a year, which may help patients to stay on therapy longer. This is important because we know that more than 60% of patients who take a once-weekly bisphosphonate stop within a year.”