Observational studyJournal of bone and mineral metabolism2017
The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.
Observational study in Journal of bone and mineral metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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The trial behind it
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Who cites it
16 citing papers in PubMed.
- Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsules in Healthy Chinese Subjects.Clinical pharmacology in drug development · 2022Trial
- Safety and Efficacy of Zoledronic Acid Treatment with and without Acetaminophen and Eldecalcitol for Osteoporosis.Internal medicine (Tokyo, Japan) · 2021Trial
- Eldecalcitol in older adults with kidney vulnerability: a narrative review of risk-based use, dose adjustment, and monitoring.Clinical and experimental nephrology · 2026Review
- Eldecalcitol and calcium supplementation in Chinese women with postmenopausal osteoporosis: a prospective observational cohort study.Journal of bone and mineral metabolism · 2026Article
- The emergence of Clade IIb and Ib mpox viruses: a state-of-the-art review.Annals of medicine and surgery (2012) · 2026Review
- Frequency of Acute Kidney Injury After the Initiation of Vitamin D Receptor Activators: A Multicenter Retrospective Observational Study.Clinical drug investigation · 2025Observational
- Pharmacologic or genetic interference with atrogene signaling protects against glucocorticoid-induced musculoskeletal and cardiac disease.JCI insight · 2024Article
- A pharmacovigilance study on clinical factors of active vitamin DScientific reports · 2024Article
- ED-71 Ameliorates Bone Loss in Type 2 Diabetes Mellitus by Enhancing Osteogenesis Through Upregulation of the Circadian Rhythm Coregulator BMAL1.Drug design, development and therapy · 2024Article
- Frequency and determinants of serum calcium monitoring during eldecalcitol therapy in patients with osteoporosis.Journal of bone and mineral metabolism · 2023Article
- Eldecalcitol effectively prevents alveolar bone loss by partially improving Th17/Treg cell balance in diabetes-associated periodontitis.Frontiers in bioengineering and biotechnology · 2023Article
- Two-year effectiveness of zoledronic acid with or without eldecalcitol in Japanese patients with osteoporosis: A randomized prospective study.Osteoporosis and sarcopenia · 2022Article
- Long-term safety of eldecalcitol in Japanese patients with osteoporosis: a retrospective, large-scale database study.Journal of bone and mineral metabolism · 2022Article
- Hypercalcemia and acute kidney injury induced by eldecalcitol in patients with osteoporosis: a case series of 32 patients at a single facility.Renal failure · 2019Observational
- The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.Journal of bone and mineral metabolism · 2019Observational
- Severe Hypocalcemia and Resulting Seizure Caused by Vitamin D Deficiency in an Older Patient Receiving Phenytoin: Eldecalcitol and Maxacalcitol Ointment as Potential Therapeutic Options for Hypocalcemia.Case reports in nephrology · 2019Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.
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