Observational studyEndocrinology and metabolism (Seoul, Korea)2022
Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea.
Observational study in Endocrinology and metabolism (Seoul, Korea), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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.
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Who cites it
15 citing papers in PubMed, 24 citations in OpenAlex.
- Effectiveness and safety of denosumab on osteoporosis treatment in kidney transplant recipients.Kidney research and clinical practice · 2026Article
- Therapeutic strategy for exosome-based bone regeneration to osteoporosis: Challenges and potential solutions.Journal of advanced research · 2026Review
- Two-year outcomes of denosumab treatment for osteoporosis comparing the effects of calcium and vitamin D supplementation.Scientific reports · 2025Article
- Updated Advances on Drugs and Bone-Targeting Nanoparticles for Osteoporosis Therapy: Carrier Materials, Modification, Function Mechanism, and Applications-A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Effects of Sequential Anti-Resorptive Agents on Bone Mineral Density Following Denosumab Withdrawal: A Multicenter Real-World Study in Korea (MAXCARE Study).Endocrinology and metabolism (Seoul, Korea) · 2025Article
- Does the Use of Denosumab in Combination with bDMARDs or tsDMARDs Increase the Risk of Infection in Patients with Osteoporosis and Inflammatory Rheumatic Diseases?Journal of clinical medicine · 2025Article
- Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use.Endocrinology and metabolism (Seoul, Korea) · 2025Review
- Denosumab in Osteoporosis: Predicting Long-Term Efficacy beyond 10 Years.Journal of bone metabolism · 2024Article
- Denosumab and the Risk of Diabetes in Patients Treated for Osteoporosis.JAMA network open · 2024Article
- Cost-consequence analysis of continuous denosumab therapy for osteoporosis treatment in South Korea.BMC musculoskeletal disorders · 2024Article
- A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for denosumab.Frontiers in pharmacology · 2024Article
- Prevalence of denosumab-induced hypocalcemia: a retrospective observational study of patients routinely monitored with ionized calcium post-injection.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024Observational
- Effect of Denosumab on Bone Density in Postmenopausal Osteoporosis: A Comparison with and without Calcium Supplementation in Patients on Standard Diets in Korea.Journal of clinical medicine · 2023Article
- Persistence with Denosumab in Male Osteoporosis Patients: A Real-World, Non-Interventional Multicenter Study.Endocrinology and metabolism (Seoul, Korea) · 2023Article
- Denosumab, an effective osteoporosis treatment option for men.The Korean journal of internal medicine · 2022Article
Corrections and comments
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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
backgruoundThe efficacy and safety of denosumab have been established in a phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with osteoporosis. This postmarketing surveillance study was aimed to investigate the safety and effectiveness of denosumab in Korean real-world clinical practice.
methodsPatients with osteoporosis who had received denosumab per the Korean approved indications in the postmarketing setting between September 2014 and September 2019 were enrolled. The primary endpoint was the incidence of adverse events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was the percent change from baseline in bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck.
resultsOf the 3,221 patients enrolled, 3,185 were included in the safety analysis set; 2,973 (93.3%) were female, and the mean± standard deviation (SD) age was 68.9±9.9 years. The mean±SD study period was 350.0±71.4 days. AEs, fatal AEs, and ADRs occurred in 19.3%, 0.8%, and 1.6%, respectively. The most frequent AEs, occurring in >0.5% of patients, were dizziness (0.7%), arthralgia (0.7%), back pain (0.6%), and myalgia (0.6%). Hypocalcemia occurred in 0.3% of patients. There were no cases of osteonecrosis of the jaw and atypical femoral fracture. Mean±SD percent change from baseline in BMD of the lumbar spine, total hip, and femoral neck was 7.3%±23.6%, 3.6%±31.4%, and 3.2%±10.7%, respectively.
conclusionThe safety and effectiveness of denosumab in Korean patients with osteoporosis in this study were comparable with those in the Korean randomized controlled trial, with no new safety findings.
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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.