[Anti-fracture efficacy of intravenous ibandronate: how to translate epidemiological studies into daily clinical practice].
Numerous epidemiological approaches are used to demonstrate the efficacy of a new chemical entity. In postmenopausal osteoporosis, anti-fracture efficacy can be assessed through prospective, randomized controlled trials, meta-analyses or real-life setting studies. Intravenous ibandronate was recently marketed, with the aim of optimizing drug absorption and adherence to treatment. Furthermore, this new formulation avoids gastrointestinal side effects and constrains linked to the oral intake of the medication. Spinal anti-fracture efficacy of IV ibandronate derives from a non-inferiority bridging study, using surrogate endpoints, i.e., bone mineral density and biochemical markers of bone turnover, compared to the oral daily formulation, previously registered for the treatment of osteoporosis in Europe. Coherent results from two separate meta-analyses have suggested that the non-vertebral anti-fracture efficacy of IV ibandronate is similar to that observed with oral, daily and weekly bisphosphonates. Similarly, a recent real-life setting study, based on claims from an US database, suggests that hip fractures are reduced, with IV ibandronate, to the same extend as they are with oral bisphosphonates. Notwithstanding, those results should probably be confirmed in an European setting, before being extrapolated, in daily practice, to the Belgian population.
Neuprez
A
A
Département des Sciences de la Santé Publique, Service de Santé Publique, Epidémiologie et Economie de la Santé, Faculté de Médecine, Université de Liège.
Hiligsmann
M
M
Bruyère
O
O
Reginster
J Y
JY
D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D015510:Clinical Medicine; D004164:Diphosphonates / Q000008:administration & dosage*; D005598:Fractures, Spontaneous / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D000077557:Ibandronic Acid; D007275:Injections, Intravenous; D010024:Osteoporosis / Q000150:complications
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid