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Proposal 1473

Title of the Proposed Research

Comparison of the pharmacokinetics of oral once-monthly 150mg ibandronate between ethnic Europeans and Taiwan post-menopausal osteoporotic women across two phase 1 studies

Lead Researcher

Keh-Sung Tsai

Affiliation

Department of Laboratory Medicine
National Taiwan University Hospital

Institute of Epidemiology and Preventive Medicine
National Taiwan University

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

30 August 2016

Lay Summary

Bisphosphonates have been shown to effectively increase bone mineral density and reduce fracture risk in osteoporotic patients (1-3). However, there has been concern about osteonecrosis of the jaws (ONJ) (4,5) and atypical femoral fractures (AFF) (6) with long-term usage of bisphosphonates. In a patient population at the University of Southern California (7), most reported ONJ patients on oral alendronate as a treatment for osteoporosis were Asian Americans. In addition, Lo et al (8) reviewed radiographic images to ascertain the presence of AFF and found that a disproportionate number of Asian women had a greater chance of experiencing AFF. The role of Asian ethnicity in the development of ONJ or AFF needs to be further investigated. One possible explanation is ethnic difference in pharmacokinetics after oral intake of bisphosphonates. Nevertheless, early studies of new pharmacological entities were frequently carried out in a small number of individuals in Western Europe or North America. Studies concerning the pharmacokinetics of oral bisphosphonates conducted in Caucasians as well as in Asians following the same protocol are sparse.

Oral monthly doses of ibandronate have been reported to be efficacious in treating osteoporosis. The pharmacokinetics (PK) and pharmacodynamics (PD) of oral once-monthly 150mg ibandronate and its efficacy and safety have been evaluated in Europeans (Roche sponsored study number: BP16331) and the results are published in a well-known endocrinology journal (JCEM 90(9):5018-5024, 2005) (9). In 2007, researchers in Taiwan also conducted a trial to explore the PK and PD parameters of oral once-monthly 150mg ibandronate in postmenopausal osteoporotic women (Roche sponsored study number, ML20793; the Institutional Review Board at National Taiwan University Hospital, 950916). Since most Asian population own smaller body sizes than Europeans, it is likely that with similar dosing formula, the pharmacokinetic results will be different among the two groups. In other word, a less frequent dosing formula or a smaller dose may be sufficient for Asians. Yet without body weight and serum creatinine adjustments, their PK and PD parameters cannot be validly compared. Using the Roche Global Data Sharing system (https://clinicalstudydatarequest.com/) anonymized original phase 1 data, our study aims to compare the pharmacokinetics (PK) of oral once-monthly 150mg ibandronate between Taiwanese and European post-menopausal osteoporotic women using same protocol and same laboratory of assay.

Study Data Provided

Study ROCHE-BP16331: A randomized, double-blind, phase 1/2, multicenter dose ranging study to determine the tolerability and effect on bone turnover of several monthly doses of ibandronate in postmenopausal women

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.