Evidence map›Paper›PMID 35740530›Full record

ArticleCancers2022

Bone Turnover Marker (BTM) Changes after Denosumab in Giant Cell Tumors of Bone (GCTB): A Phase II Trial Correlative Study.

Emanuela Palmerini, Laura Pazzaglia, Luca Cevolani, Loredana Pratelli, Michela Pierini, Irene Quattrini, Elisa Carretta, Maria Cristina Manara, Michela Pasello, Giorgio Frega and 11 more

Open access · goldAbstract read
In one paragraph

Article in Cancers, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 24% 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

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. 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

21 authors at 1 institution in 1 country.

Emanuela PalmeriniOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.ORCID 0000-0003-3406-6705
Laura PazzagliaSSD Laboratory of Experimental Oncology, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.ORCID 0000-0001-5937-4953
Luca CevolaniThird Orthopaedic Clinic and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.ORCID 0000-0002-3190-1034
Loredana PratelliDepartment of Pathology, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Michela PieriniOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Irene QuattriniScientific Direction IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Elisa CarrettaOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.ORCID 0000-0002-4534-6000
Maria Cristina ManaraSSD Laboratory of Experimental Oncology, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.ORCID 0000-0001-5686-720X
Michela PaselloSSD Laboratory of Experimental Oncology, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.ORCID 0000-0002-2020-9376
Giorgio FregaOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Anna PaioliOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Alessandra LonghiOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.ORCID 0000-0001-6708-3777
Marilena CesariOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Rossella HakimOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Toni IbrahimOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.ORCID 0000-0003-0259-4167
Laura CampanacciThird Orthopaedic Clinic and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.ORCID 0000-0002-4734-6741
Eric Lodewijk StaalsThird Orthopaedic Clinic and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Davide Maria DonatiThird Orthopaedic Clinic and Traumatology, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Maria Serena BenassiSSD Laboratory of Experimental Oncology, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.
Katia ScotlandiSSD Laboratory of Experimental Oncology, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.ORCID 0000-0001-6114-9499
Stefano FerrariOsteoncology, Bone and Soft Tissue Sarcoma and Innovative Therapy, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy.
Istituto Ortopedico Rizzoli · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Giant cell tumors of bone (GCTB) are osteolytic tumors. Denosumab, a RANK-L inhibitor, is approved for GCTB. Data on serum bone turnover marker (sBTM) changes are lacking. We present a phase II correlative study on sBTMs in GCTB patients treated with denosumab. Methods: All GCTB patients receiving denosumab within a multicentre, open-label, phase 2 study were enrolled. Serum levels of carboxyterminal-crosslinked-telopeptide of type I collagen (s-CTX), alkaline phosphatase (ALP), bone-alkaline phosphatase (bALP), parathyroid hormone (sPTH), and osteocalcin (OCN) were prospectively assessed (baseline, T0, 3 months, T1, 6 months, T2). The primary endpoint was assessment of sBTM changes after denosumab; the secondary endpoints were disease-free survival (DFS) and sBTM correlation. Results: In 54 cases, sBTMs decreased during denosumab treatment except for sPTH. With a median follow-up of 59 months, 3-year DFS was 65% (%CI 52−79), with a significantly worse outcome for patients with high (≥500 UI/mL) s-CTX at baseline, as compared to low s-CTX (<500 UI/mL) (3-year DFS for high CTX 45% (95%CI 23−67) vs. 75% (95%CI 59−91) for low s-CTX. Higher median ALP and s-CTX were found for patients with tumor size ≥ 5 cm (p = 0.0512; p = 0.0589). Conclusion: Denosumab induces ALP/OCN and s-CTX reduction. High baseline s-CTX identifies a group of patients at higher risk of progression of the disease.

Indexed as

bone turnover markerscarboxyterminal crosslinked telopeptide of type I collagendenosumabgiant cell tumor of bone

Identifiers

PMID35740530
PMCPMC9220940
OpenAlexW4281643358

What OpenQuestion holds

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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.