Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2018
Modeling and simulation of bone mineral density in Japanese osteoporosis patients treated with zoledronic acid using tartrate-resistant acid phosphatase 5b, a bone resorption marker.
Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 19 citations in OpenAlex.
- Prediction of Fracture Risk From Early-Stage Bone Markers in Patients With Osteoporosis Treated With Once-Yearly Administered Zoledronic Acid.Journal of clinical pharmacology · 2021Trial
- Safety Profiles, Pharmacokinetics, and Changes in Bone Turnover Markers After Twice-Weekly Subcutaneous Administration of Teriparatide in Healthy Japanese Postmenopausal Women: A Single-Blind Randomized Study.Clinical pharmacology in drug development · 2020Trial
- Temporal patterns of osteoclast formation and activity following withdrawal of RANKL inhibition.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2024Article
- Optimization of the dosage regimen of zoledronic acid with a kinetic-pharmacodynamic model and exposure-response analysis.Frontiers in pharmacology · 2023Article
- Zoledronic Acid Deteriorates Soft and Hard Tissue Healing of Murine Tooth Extraction Sockets in a Dose-Dependent Manner.Calcified tissue international · 2022Article
- Pre-screening for osteoporosis with calcaneus quantitative ultrasound and dual-energy X-ray absorptiometry bone density.Scientific reports · 2021Article
- Icariin Prevents Diabetes-Induced Bone Loss in Rats by Reducing Blood Glucose and Suppressing Bone Turnover.Molecules (Basel, Switzerland) · 2019Article
- Medical Treatment for Osteoporosis: From Molecular to Clinical Opinions.International journal of molecular sciences · 2019Review
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Annual intravenous administration of zoledronic acid is used in the treatment of osteoporosis. A mathematical model was developed to predict bone mineral density up to 2 years after two annual doses of zoledronic acid from the early values of a bone resorption marker in osteoporosis patients.
introductionThe measurement of bone mineral density (BMD) has been used as a surrogate marker instead of the observation of incident fractures to detect the efficacy of treatment. However, this method requires a long time to obtain significant changes. On the other hand, bone resorption markers respond to bone resorption inhibitors within a few weeks. Therefore, the aim of this study was to develop a mathematical model predicting long-term BMD after two annual doses of zoledronic acid (ZOL) using the early response of a bone resorption marker in osteoporosis patients.
methodsThe model was constructed using 3410 tartrate-resistant acid phosphatase 5b (TRACP-5b) serum concentrations and 1146 lumbar spine (L2-L4) BMD values from 306 patients with primary osteoporosis. A mathematical model was developed to describe the time-dependent profiles of TRACP-5b and BMD.
resultsThe percentage changes from baseline of the BMD (%BMD) at up to 2 years were predicted from patients' baseline BMD and baseline and 12-week TRACP-5b values by the model obtained. The simulated 90% prediction interval almost covered the observed %BMD distribution at each time point, and the predictions were comparable to the observed %BMD.
conclusionsThis is the first model to predict BMD for up to 2 years following two annual doses of ZOL using patients' background characteristics and the early response of TRACP-5b. This model allows us to inform patients at the initial stage of ZOL treatment of their predicted response to treatment.
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