Once-monthly dosing of Roche and GlaxoSmithKline’s post menopausal osteoporosis treatment, Bonviva/Boniva (ibandronate), is at least as effective as the once daily version of the pill, according to new two-year data from the companies.
The Phase III trial, known as Mobile, included 1,609 women with postmenopausal osteoporosis who received either monthly or daily oral doses of Boniva. The 150mg Bonviva monthly regimen performed significantly better than the 2.5mg daily version. Lumbar spine bone mineral density increased in all groups – specifically 5.6% and 6.6% in the 100 mg and 150mg once monthly groups respectively, versus 5% in the daily group. BMD at all regions of the hip increased for all treatment groups, and were most pronounced in the 150mg group (3.5% and 4.2% in the 100mg and 150mg once monthly groups respectively, compared with 2.5% in the daily group). Furthermore, decreases in markers of bone turnover seen during the first year were maintained throughout the second year.
William Burns, chief executive of Roche’s pharmaceutical division, commented: “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.”
Boniva was approved in the USA in March [[29/03/05a]], and the firms are currently awaiting the green light from the European regulatory authority [[20/09/04c]].