Trial reportJournal of pharmacokinetics and pharmacodynamics2013
Application of a mechanism-based disease systems model for osteoporosis to clinical data.
Trial report in Journal of pharmacokinetics and pharmacodynamics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 30 citations in OpenAlex.
- Disease Systems Analysis of Bone Mineral Density and Bone Turnover Markers in Response to Alendronate, Placebo, and Washout in Postmenopausal Women.CPT: pharmacometrics & systems pharmacology · 2016Trial
- Application of modeling and simulation to a long-term clinical trial: a direct comparison of simulated data and data actually observed in Japanese osteoporosis patients following 3-year ibandronate treatment.Clinical pharmacokinetics · 2015Trial
- Mathematical modeling of bone remodeling after surgical menopause.Frontiers in systems biology · 2026Article
- Role of SOST in Response to Mechanical Stimulation in Bone and Extraosseous Organs.Biomolecules · 2025Review
- A review of mathematical modeling of bone remodeling from a systems biology perspective.Frontiers in systems biology · 2024Article
- Network Pharmacology of Adaptogens in the Assessment of Their Pleiotropic Therapeutic Activity.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Assessment of Strategies for Safe Drug Discontinuation and Transition of Denosumab Treatment in PMO-Insights From a Mechanistic PK/PD Model of Bone Turnover.Frontiers in bioengineering and biotechnology · 2022Article
- Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices.The AAPS journal · 2019Review
- Pharmacometrics and systems pharmacology for metabolic bone diseases.British journal of clinical pharmacology · 2019Review
- Kinetics of drug action in disease states: towards physiology-based pharmacodynamic (PBPD) models.Journal of pharmacokinetics and pharmacodynamics · 2015Article
- Modeling effects of dexamethasone on disease progression of bone mineral density in collagen-induced arthritic rats.Pharmacology research & perspectives · 2015Article
- Application of a Systems Pharmacology-Based Placebo Population Model to Analyze Long-Term Data of Postmenopausal Osteoporosis.CPT: pharmacometrics & systems pharmacology · 2015Article
- A semi-mechanistic model of bone mineral density and bone turnover based on a circular model of bone remodeling.Journal of pharmacokinetics and pharmacodynamics · 2015Article
- The osteocyte as a therapeutic target in the treatment of osteoporosis.Therapeutic advances in musculoskeletal disease · 2014Review
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A recently proposed mechanism-based disease systems model for osteoporosis (Schmidt et al., J Pharmacokinet Pharmacodyn 38:873-900, 2011) was applied to clinical data from post-menopausal women (n = 767) receiving various doses of the selective estrogen receptor modulator tibolone. Plasma bone-specific alkaline phosphatase activity and urinary N-telopeptide were used as biomarkers reflecting the activity of osteoblasts (bone forming cells) and osteoclasts (bone removing cells), respectively. These data were analyzed in conjunction with data on osteocalcin and on bone mineral density (BMD) (both lumbar spine and total hip), which reflect the activity of both cell types. While the dynamics of bone turnover markers changes rapidly, closely following changes in the activity of bone cells, changes in BMD are slower and have their own dynamics. Application of the mechanism-based disease systems model to the clinical data allowed for an adequate description of the data and yielded parameter estimates that are consistent with physiological values reported in the literature (Lemaire et al., J Theor Biol 229:293-309, 2004). The fitted model enabled characterization of (i) the critical time scales involved in disease progression, (ii) the dynamics of the system during onset and offset of the therapeutic intervention, and (iii) the distinction between responders and low-responders to tibolone treatment.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.