Evidence map›Paper›PMID 33145606›Full record

SynthesisOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2021

Denosumab is not associated with risk of malignancy: systematic review and meta-analysis of randomized controlled trials.

D Rosenberg, T Avni, G Tsvetov, A Gafter-Gvili, T Diker-Cohen

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 35% of its field
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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Denosumab vs. bisphosphonates in primary osteoporosis: a meta-analysis of comparative safety in randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
    Pooled it
  2. Management of skeletal-related events and fracture prevention in systemic mastocytosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Review
  3. Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use.Endocrinology and metabolism (Seoul, Korea) · 2025
    Review
  4. RANKL biology.Bone · 2022
    Review
  5. Denosumab is not associated with risk of malignancy? More evidence is needed.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Article
  6. Denosumab is not associated with risk of malignancy: systematic review and meta-analysis of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Article
  7. Should denosumab treatment for osteoporosis be continued indefinitely?Therapeutic advances in endocrinology and metabolism · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

D RosenbergMedicine A, Rabin Medical Center - Beilinson Hospital, 39 Jabotinski St., 4941492, Petach Tikva, Israel. roza.dana@gmail.com.ORCID https://orcid.org/0000-0002-1968-3791
T AvniMedicine A, Rabin Medical Center - Beilinson Hospital, 39 Jabotinski St., 4941492, Petach Tikva, Israel.
G TsvetovSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
A Gafter-GviliMedicine A, Rabin Medical Center - Beilinson Hospital, 39 Jabotinski St., 4941492, Petach Tikva, Israel.
T Diker-CohenMedicine A, Rabin Medical Center - Beilinson Hospital, 39 Jabotinski St., 4941492, Petach Tikva, Israel.ORCID https://orcid.org/0000-0001-6211-2073
Tel Aviv University · ILRabin Medical Center · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The immunomodulatory effects of denosumab have raised concerns for risk of malignancy. This meta-analysis of 25 randomized controlled trials (21,523 patients) shows similar risk of malignancy between denosumab (60 mg every 6 months, up to 48 months) and any comparator. Post-marketing surveillance may detect rare or late-occurring drug effects. Possible increased risk of malignancy in patients treated with denosumab has been concerned due to inhibition of the immune modulator receptor activator of nuclear factor κ-Β ligand (RANKL). We aimed to assess the risk of malignancy associated with denosumab treatment. PubMed and Cochrane Central Register of Controlled Trials were searched up to May 27, 2019 to include all randomized controlled trials of denosumab (60 mg every 6 months) versus any comparator. Trials using higher drug doses for prevention of skeletal-related events were excluded. Data were independently extracted by two reviewers and analyzed using a fixed-effect model to pool risk ratios (RRs) with 95% confidence intervals (CI). Twenty-five trials (21,523 patients) were included. The risk of malignancy was similar between denosumab and other comparators (absolute risk difference 0%, RR 1.08 [95% CI, 0.93-1.24], I

Indexed as

Bone Density Conservation AgentsNeoplasmsDenosumabHumansRandomized Controlled Trials as TopicBone Density Conservation AgentsDenosumabAdverse eventsAnti RANK ligandDenosumabMalignancyMeta-analysisOsteoporosis

Identifiers

PMID33145606
OpenAlexW3095085286

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.