Evidence map›Paper›PMID 25990355›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2015

Denosumab versus zoledronic acid in patients previously treated with zoledronic acid.

A D Anastasilakis, S A Polyzos, A Gkiomisi, Z G Saridakis, D Digkas, I Bisbinas, G T Sakellariou, A Papatheodorou, P Kokkoris, P Makras

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 12 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

34 citing papers in PubMed, 12 syntheses or guidelines pooled it.

  1. Pooled it
  2. A systematic review and meta-analysis of sequential treatment strategies for osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
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  5. 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
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  15. The Effect of Zoledronic Acid on Bone Microarchitecture and Strength after Denosumab and Teriparatide Administration: DATA-HD Study Extension.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2023
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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

10 authors.

A D AnastasilakisDepartment of Endocrinology, 424 General Military Hospital, Ring Road, 564 29 N.Efkarpia, Thessaloniki, Greece. anastath@endo.gr.
S A PolyzosSecond Medical Clinic, Department of Medicine, Ippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
A GkiomisiDepartment of Obstetrics and Gynaecology, 424 General Military Hospital, Thessaloniki, Greece.
Z G SaridakisHellenic Military School of Medicine, Thessaloniki, Greece.
D DigkasHellenic Military School of Medicine, Thessaloniki, Greece.
I Bisbinas1st Department of Orthopaedics, 424 General Military Hospital, Thessaloniki, Greece.
G T SakellariouDepartment of Rheumatology, 424 General Military Hospital, Thessaloniki, Greece.
A PapatheodorouDepartment of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.
P KokkorisDepartment of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.
P MakrasDepartment of Endocrinology and Diabetes, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledDenosumab and zoledronic acid are potent antiresorptives. In this study in patients pre-treated with zoledronic acid, denosumab achieved similar increases with zoledronic acid in lumbar spine BMD despite the more prominent reduction of bone turnover markers. Denosumab reversibly reduced endogenous RANKL.

introductionWe aimed to compare yearly changes in lumbar spine (LS) bone mineral density (BMD), bone turnover markers, free soluble receptor activator of nuclear factor kappaB ligand (sRANKL) and sclerostin levels between denosumab and zoledronic acid.

methodsPostmenopausal women with low bone mass previously treated with zoledronic acid for 1 year were assigned to denosumab injection (n = 32) or zoledronic acid infusion (n = 26). Procollagen type 1 N-terminal propeptide (P1NP), C-terminal cross-linking telopeptide of type 1 collagen (CTx), sRANKL, and sclerostin levels were measured in serum samples obtained at baseline and 3, 6, and 12 months after denosumab injection or zoledronic acid infusion. LS BMD was measured at baseline and 12 months.

resultsThe mean LS increase was 4.5 and 4.4% with denosumab and zoledronic acid, respectively (p = 0.560). Denosumab caused a larger decrease in CTx at 3 months (p < 0.001) and P1NP at 3 (p < 0.001), 6 (p = 0.021), and 12 months (p = 0.042). Denosumab significantly decreased sRANKL by 87.4% at 3 months (p < 0.001). Sclerostin levels were not changed with either intervention (p = 0.162 and p = 0.214, respectively).

conclusionsIn patients previously treated with zoledronic acid, denosumab reduces bone turnover more than zoledronic acid, but the increases in LS BMD are comparable. Furthermore, denosumab administration results in reversible inhibition of the metabolically significant endogenous free soluble RANKL levels. Serum sclerostin is not affected by either agent.

Indexed as

Adaptor Proteins, Signal TransducingAgedBiomarkersBone DensityBone Density Conservation AgentsBone Morphogenetic ProteinsDenosumabDiphosphonatesDrug Therapy, CombinationFemaleGenetic MarkersHumansImidazolesLumbar VertebraeMiddle AgedOsteoporosis, PostmenopausalAdaptor Proteins, Signal TransducingBiomarkersBone Density Conservation AgentsBone Morphogenetic ProteinsDenosumabDiphosphonatesGenetic MarkersImidazolesRANK LigandSOST protein, humanTNFSF11 protein, humanZoledronic AcidBone mineral densityBone turnover markersDenosumabRANKLSclerostinZoledronic acid

Identifiers

PMID25990355

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.