Open AccessApplication of a Systems Pharmacology‐Based Placebo Population Model to Analyze Long‐Term Data of Postmenopausal Osteoporosis
Author(s) -
Berkhout J,
Stone JA,
Verhamme KM,
Stricker BH,
Sturkenboom MC,
Danhof M,
Post TM
Publication year - 2015
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12006
Subject(s) - placebo , osteoporosis , medicine , cohort , population , bone disease , physical therapy , postmenopausal osteoporosis , bone mineral , disease , alternative medicine , pathology , environmental health
Osteoporosis is a progressive bone disease characterized by decreased bone mass resulting in increased fracture risk. The objective of this investigation was to test whether a recently developed disease systems analysis model for osteoporosis could describe disease progression in a placebo‐treated population from the Early Postmenopausal Intervention Cohort (EPIC) study. First, we qualified the model using a subset from the placebo arm of the EPIC study of 222 women who had similar demographic characteristics as the 149 women from the placebo arm of the original population. Second, we applied the model to all 470 women. Bone mineral density (BMD) dynamics were changed to an indirect response model to describe lumbar spine and total hip BMD in this second population. This updated disease systems analysis placebo model describes the dynamics of all biomarkers in the corresponding datasets to a very good approximation; a good description of an individual placebo response will be valuable for evaluating treatments for osteoporosis.