Evidence map›Paper›PMID 27394428›Full record

Observational studyJournal of nephrology2017

Safety and efficacy of denosumab in osteoporotic hemodialysed patients.

Francescaromana Festuccia, Maryam Tayefeh Jafari, Alessandra Moioli, Claudia Fofi, Simona Barberi, Stefano Amendola, Salvatore Sciacchitano, Giorgio Punzo, Paolo Menè

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of nephrology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Osteoporosis in Patients with Chronic Kidney Diseases: A Systemic Review.International journal of molecular sciences · 2020
    Pooled it
  2. Hypocalcemia and bone mineral density changes following denosumab treatment in end-stage renal disease patients: a meta-analysis of observational studies.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2018
    Pooled it
  3. Trial
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  7. Characteristics and treatment options of 272,152 geriatric patients with very high and high fracture risk.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Article
  8. Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use.Endocrinology and metabolism (Seoul, Korea) · 2025
    Review
  9. Review
  10. Article
  11. Observational
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  15. Article
  16. Review
  17. Review
  18. Management of osteoporosis 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 · 2022
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Francescaromana FestucciaNephrology and Dialysis Unit, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy. frarom73@yahoo.com.ORCID http://orcid.org/0000-0001-7727-2280
Maryam Tayefeh JafariNephrology and Dialysis Unit, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy.
Alessandra MoioliNephrology and Dialysis Unit, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy. moioli.am@gmail.com.
Claudia FofiNephrology and Dialysis Unit, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy.
Simona BarberiNephrology and Dialysis Unit, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy.
Stefano AmendolaSection of Endocrinology and Diabetology, Ospedale Israelitico, Rome, Italy.
Salvatore SciacchitanoDepartment of Clinical and Molecular Medicine, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy.
Giorgio PunzoNephrology and Dialysis Unit, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy.
Paolo MenèNephrology and Dialysis Unit, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Sant'Andrea Hospital, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsIn elderly subjects, renal insufficiency and osteoporosis often coexist with high risk of fracture and elevated socio-economic burden. Today a large number of effective anti-osteoporotic drugs are available but generally they are contraindicated in patients with chronic kidney disease (CKD) because of their progressive accumulation. Denosumab, instead, does not require dose adjustments for different degrees of renal impairment so it can be a valid treatment in osteoporotic patients with CKD. Limited data are available in the literature concerning the use of denosumab in hemodialysis (HD). The aim of our study was, therefore, to study the efficacy and tolerability of this drug in this particular subset of patients.

methodsWe retrospectively reviewed the charts of 12 osteoporotic HD patients who received a single 60-mg subcutaneous dose of denosumab every 6 months for an observation period of 24 months. Serum electrolyte, markers of bone turnover and quantitative ultrasound (QUS) were evaluated.

resultsOver 24 months, we observed a gradual improvement of bone metabolism: β-CrossLaps from 2567.08 ± 1264 to 1492.5 ± 1182.5 pg/ml; bone alkaline phosphatase (BALP) from 33.5 ± 28.8 to 11.8 ± 3.7 mcg/l, and of QUS index (T-score from -5.33 ± 1.58 to -4.84 ± 1.2; risk of fracture from 13.9 ± 4.7 to 11.07 ± 5.3 %). Few cases of hypocalcemia were detected, more significant after the first and second injection, but with careful monitoring of serum calcium and rapid therapy adjustment we could easily manage serum Ca levels.

conclusionsOur pilot experience highlights the safety and efficacy of denosumab in the treatment of osteoporosis in HD patients, potentially supporting its use to reduce the burden of fractures in this patient population.

Indexed as

Renal DialysisAgedAged, 80 and overBiomarkersBone Density Conservation AgentsBone RemodelingCalciumDenosumabFemaleHumansHypocalcemiaMaleMiddle AgedOsteoporosisPilot ProjectsRenal Insufficiency, ChronicBiomarkersBone Density Conservation AgentsCalciumDenosumabDenosumabHemodialysisHypocalcemiaOsteoporosisQuantitative ultrasound

Identifiers

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Registered trials

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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.