Trial reportKidney international2015
Bone histomorphometry before and after long-term treatment with cinacalcet in dialysis patients with secondary hyperparathyroidism.
Trial report in Kidney international, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00261950 (Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease), which is not on this map. Cited by 82 papers, 3 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.
Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Who cites it
82 citing papers in PubMed, 3 syntheses or guidelines pooled it, 177 citations in OpenAlex.
- Effectiveness of calcimimetics on fractures in dialysis patients with secondary hyperparathyroidism: meta-analysis of randomized trials.Journal of bone and mineral metabolism · 2024Pooled it
- Cinacalcet use in secondary hyperparathyroidism: a machine learning-based systematic review.Frontiers in endocrinology · 2023Pooled it
- Osteoporosis in Patients with Chronic Kidney Diseases: A Systemic Review.International journal of molecular sciences · 2020Pooled it
- Trial
- Trial
- A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM).Clinical journal of the American Society of Nephrology : CJASN · 2015Trial
- Mineral and Bone Disease in CKD and Kidney Transplantation: Controversies, Gaps, and a Path Forward.Kidney international reports · 2026Review
- Chronic kidney disease: from mineral dysregulation to bone and cardiovascular disease.Journal of endocrinological investigation · 2026Review
- Association of serum magnesium levels and calcimimetic use: fractures and cardiovascular events in Japanese haemodialysis patients.Journal of bone and mineral metabolism · 2026Article
- The Conundrum of Medical Fracture Prevention in Chronic Kidney Disease-Summary of the Evidence and Pragmatic Clinical Guidance.Journal of clinical medicine · 2025Review
- Bone in Parathyroid Diseases Revisited: Evidence From Epidemiological, Surgical and New Drug Outcomes.Endocrine reviews · 2025Review
- Calcimimetics and Vascular Calcification.Toxins · 2025Review
- Time-lapse HR-pQCT reliably assesses and monitors local bone turnover in patients with chronic kidney disease.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025Article
- Decoding pathology: the role of computational pathology in research and diagnostics.Pflugers Archiv : European journal of physiology · 2025Review
- Pathophysiology and therapies of CKD-associated secondary hyperparathyroidism.Clinical kidney journal · 2025Article
- Roles of Parathyroid Hormone and Fibroblast Growth Factor 23 in Advanced Chronic Kidney Disease.Endocrinology and metabolism (Seoul, Korea) · 2024Review
- Effect of Tempeh and Daidzein on Calcium Status, Calcium Transporters, and Bone Metabolism Biomarkers in Ovariectomized Rats.Nutrients · 2024Article
- Mixed uremic osteodystrophy: an ill-described common bone pathology in patients with chronic kidney disease.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023Review
- Management of fracture risk in CKD-traditional and novel approaches.Clinical kidney journal · 2023Review
- Article
22 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The multicenter, single-arm BONAFIDE study characterized the skeletal response to cinacalcet in adult dialysis patients with plasma parathyroid hormone (PTH) levels of 300 pg/ml or more, serum calcium of 8.4 mg/dl or more, bone-specific alkaline phosphatase over 20.9 ng/ml and biopsy-proven high-turnover bone disease. Of 110 enrolled patients, 77 underwent a second bone biopsy with quantitative histomorphometry after 6-12 months of cinacalcet treatment. The median PTH decreased from 985 pg/ml at baseline to 480 pg/ml at the end of study (weeks 44-52). Bone formation rate/tissue area decreased from 728 to 336 μm(2)/mm(2)/day, osteoblast perimeter/osteoid perimeter decreased from 17.4 to 13.9%, and eroded perimeter/bone perimeter decreased from 12.7 to 8.3%. The number of patients with normal bone histology increased from none at baseline to 20 at 12 months. Two patients had adynamic bone at the end of study with a PTH under 150 pg/ml, and one patient with overt hypophosphatemia at baseline that reoccurred during follow-up developed osteomalacia. Thus, long-term treatment with cinacalcet substantially reduced PTH, diminished the elevated bone formation rate/tissue area, lowered several biochemical markers of high-turnover bone disease toward normal, and generally improved bone histology. Twenty patients had normal bone histology at follow-up, whereas most had mild hyperparathyroidism or mixed uremic osteodystrophy.
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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.