ArticleJournal of clinical pharmacology2022
Influence of Renal Function on Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose of Romosozumab.
Article in Journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01833754 (A Phase 1, Open-label, Single-dose Study of Romosozumab), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
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.
A Phase 1, Open-label, Single-dose Study of Romosozumab (AMG 785) Administered Subcutaneously to Healthy Subjects and Subjects With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Romosozumab for the treatment of osteoporosis - a systematic review.Journal of endocrinological investigation · 2025Pooled it
- Romosozumab adverse event profile: a pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) from 2019 to 2023.Aging clinical and experimental research · 2025Pooled it
- Four weeks of romosozumab treatment increases trabecular bone volume and differentially improves cortical bone in young and aging mice with chronic kidney disease.Calcified tissue international · 2026Article
- Prescription of off-label medications in patients on dialysis: time to challenge contraindications?Clinical kidney journal · 2026Review
- Clinical approaches to osteoporosis in patients with chronic kidney disease: A comprehensive review.Endocrine journal · 2025Review
- Treatment of Osteoporosis in Patients with Chronic Kidney Disease.Current osteoporosis reports · 2025Review
- Romosozumab for managing severe osteoporosis in patients undergoing kidney transplantation: a retrospective case series.JBMR plus · 2025Article
- The effects of type 1 and type 2 diabetes mellitus on bone health in chronic kidney disease.Nature reviews. Endocrinology · 2025Review
- Article
- Τhe story of sclerostin inhibition: the past, the present, and the future.Hormones (Athens, Greece) · 2025Review
- A practical approach for anabolic treatment of bone fragility with romosozumab.Journal of endocrinological investigation · 2024Review
- Extending the Therapeutic Potential: Romosozumab in Osteoporosis Management.Journal of the Endocrine Society · 2024Review
- Romosozumab rescues impaired bone mass and strength in a murine model of diabetic kidney disease.Bone reports · 2024Article
- Osteoporosis: Spotlight on current approaches to pharmacological treatment.Turkish journal of physical medicine and rehabilitation · 2023Review
- Management of fracture risk in CKD-traditional and novel approaches.Clinical kidney journal · 2023Review
- Romosozumab improves low bone mineral density in a postmenopausal woman undergoing chronic hemodialysis and treated with a calcium-sensing receptor agonist.Bone reports · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We evaluated the pharmacokinetics, pharmacodynamics, and safety of a single subcutaneous dose of romosozumab 210 mg, a monoclonal antibody against sclerostin, in an open-label, parallel-group study in participants with severe (stage 4) renal impairment (RI; n = 8) or end-stage renal disease requiring hemodialysis (ESRD-RH; n = 8), or healthy participants with normal renal function (n = 8). Compared with the group with normal renal function, the mean romosozumab exposure was 31% and 43% higher as measured by maximum observed serum concentration and area under the concentration-time curve, respectively, in the severe RI group and similar to those in the ESRD-RH group. For all 3 groups, the maximum mean percent increase in procollagen type 1 N terminal propeptide and decrease in serum C-telopeptide levels from baseline were observed on day 15. Changes in procollagen type 1 N terminal propeptide and serum C-telopeptide were of similar patterns in all 3 groups. The single dose of romosozumab 210 mg was well tolerated. Adverse events (AEs) were reported for 13 patients (7 patients with severe RI and 6 with ESRD-RH), with no deaths, AEs, or serious AEs leading to withdrawal. The incidence of subjects with postbaseline transient decreases in serum calcium (severe RI, n = 1; ESRD-RH, n = 5) and increases in intact parathyroid hormone (severe RI, n = 7; ESRD-RH, n = 7; healthy, n = 3) were greater in severe RI and ESRD-RH groups than in the healthy group. All reported events of hypocalcemia (severe RI, n = 1; ESRD-RH, n = 4) were asymptomatic. These results support the use of romosozumab without dose adjustment in patients with severe RI or ESRD-RH.
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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.