Compliance and Efficacy of Ibandronate 3 mg iv Quaterly vs. Oral Alendronate Real World Data with the Non-interventional Study VIVA

Compliance and Efficacy of Ibandronate 3 mg iv Quarterly vs. Oral Alendronate Real World Data with the Non-interventional Study VIVA

Kliebe C, Seker-Pektas B, Funk E, Bauer M, Naumann A, Hadji P

Philipps-University of Marburg,
Department of Endocrinology, Reproductive Medicine and Osteoporosis

Purpose:

Numerous clinical trials have demonstrated the efficacy of Bisphosphonates in the treatment of postmenopausal osteoporosis. Bisphosphonates have been shown to be an effective treatment with regard to risk reduction of bone loss, osteoporosis related fractures, bone pain and as such are currently the standard of care treatment. However, the translation of clinical study results to real world experience is dependent on treatment compliance which in RCTs is generally high while in clinical practice significantly lower. This is generally true for many chronic diseases where patient adherence to treatment has been shown to be poor, which is particularly the case for oral bisphosphonates. Oral formulations of bisphosphonates are associated with poor gastrointestinal absorption, an increase in gastrointestinal adverse events necessitating complicated dosing regimens. It is well known that suboptimal adherence to bisphosphonate therapy is associated with an increased risk of fracture. In contrast to the poor adherence with oral bisphosphonates, the treatment with Ibandronate iv seem to guarantee an optimal absorption and adherence, because it is applied directly by the physician.
The objective of this non-interventional study is to investigate compliance and persistence of patients with Ibandronate 3 mg iv quarterly vs. alendronate 70 mg weekly in a real world setting. Additionally the management and controllability of intravenous Ibandronate vs. oral alendronate is assessed. Furthermore the impact of compliance and persistence and of intravenous or oral therapy on important factors reflecting real life efficacy like pain intensity, quality of life, mobility and incidence of new osteoporotic fractures will be investigated. Additionally, for the first time relating to PMO, patient questionnaires for the prospective assessment of probable compliance (SSAS and BMQ) are used in this study.
Methods: This non-interventional study has started in Germany in the end of March 2010. Overall 6.000 patients with postmenopausal osteoporosis will be enrolled by 1.500 to 2.000 office based physicians. Since the interest of this study is focused mainly on Ibandronate, a 3:1 ratio Ibandronate iv : alendronate has been chosen. The observation period per patient is 12 months. Final results are expected in autumn 2012. Together with more details on the study outline first insights on progression of recruitment of this important study will be presented.