The data of the phase III study, MOBILE, confirm Bonviva a once-monthly oral treatment for postmenopausal osteoporosis, is highly effective and well tolerated over two years.

Bonviva ( Ibandronic Acid ) is a bisphosphonate.

The two year study results show once monthly oral Bonviva is at least as effective as the approved once daily oral Bonviva.

The 150mg Bonviva monthly regimen was prospectively demonstrated to be significantly better than the 2.5mg Bonviva daily regimen.

- Lumbar spine bone mineral density ( BMD ) increased in all groups: 5.3%, 5.6% and 6.6% in the 50+50 mg,100 mg and 150mg once monthly groups respectively, compared with 5.0% in the daily group. The 150mg regimen continued to be superior to daily Bonviva ( p < 0.001 ).

- BMD at all regions of the hip increased for all treatment groups, but increases were most pronounced in the 150mg group: 3.5% and 4.2% ,100 mg and 150mg once monthly groups respectively, compared with 2.5% in the daily group at the total hip

- Decreases in markers of bone turnover seen during the first year of MOBILE were maintained throughout the second year.

- The majority of participants responded positively to oral Ibandronate therapy. In the 150mg once-monthly group over 80% of patients maintained or gained BMD at all sites measured.

These two year data also confirm the good tolerability previously seen at one year:

- Incidence of adverse events with once monthly oral Bonviva was similar to that seen in the daily group.

- No unexpected significant upper gastro-intestinal ( GI ) safety concerns were identified and there were very few withdrawals due to adverse effects.

Current bisphosphonate therapies are available as daily and weekly dosing formulations.

MOBILE ( Monthly Oral iBandronate In LadiEs ) is a two-year, randomized, double-blind trial in 1609 women with postmenopausal osteoporosis comparing the efficacy and safety of monthly oral doses of Ibandronate ( 100mg on a single day; 100mg as separate 50mg doses on two consecutive days; or 150mg on a single day ) versus the oral daily regimen ( 2.5mg ).

Bonviva, like other orally administered bisphosphonates, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer.

Source: Annual European Congress of Rheumatology, EULAR 2005


XagenaMedicine2005