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OpenTrials
Completed

NCT Number: NCT03415477

Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts

The efficacy of traditional therapeutic approaches for aneurysmal bone cysts (ABC), such as surgery, embolization, sclerotherapy and radiotherapy, are often compromised for lesions in axial skeletons and adolescents complicated with pathological fracture. Therefore, denosumab, a new drug that has been successfully used in giant cell tumor of bone but has seldom used in ABC, was used to treat ABC in this trial.

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Key information

About this study

Patients with primary ABC treated with perioperative denosumab in the Musculoskeletal Tumor Center of Peking University People's Hospital between January 2014 and December 2016 will be reported in this trial.Approved by the Ethics Committee of Peking University People's Hospital and with the full informed consent from the patients or their families, all patients received surgery and treatment with denosumab perioperatively. Denosumab 120 mg was given subcutaneously (abdomen wall or upper arms) every 4 weeks (Q4W), with a loading dose on both Day 8 and Day 15 of the first cycle. Meanwhile, all patients were suggested to take 800mg oral calcium supplement every day and avoid any dental or oral surgery (tooth extraction, tooth filling, etc.). Patients were followed once a month since the date of surgery. On follow-up visits, patient-reported adverse reactions, X-ray image of jawbone, serum calcium, alkaline phosphatase, renal and hepatic function, hemoglobin, white blood cell, and platelet count were collected, and histological examinations, radiological examinations (such as X-ray, computed tomography (CT), magnetic resonance image (MRI) and positron emission tomography-computed tomography (PET-CT) and postoperative functional status evaluations by MSTS(Musculoskeletal tumor society) score were conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pathologically diagnosed with primary aneurysmal bone cyst
  • lesions in axial skeletons (i.e. spine, pelvis) which are difficult to reach a satisfactory surgical margin, and surgery can lead to very high incidence of complications.
  • pathological fracture
  • recurrence cases

Exclusion criteria

  • metastases or multi-focal lesions
  • malignancy

Treatment and study plan

Denosumab (Xgeva)

Drug

Denosumab (Xgeva) 120 mg was given subcutaneously (abdomen wall or upper arms) every 4 weeks (Q4W), with a loading dose on both Day 8 and Day15 of the first cycle, perioperatively.

Other names: surgical treatment

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: at least 1-year

    the number of participats (complete response+ partial response according to RECIST 1.1)/ total participants number.

  2. local control rate

    Time frame: at least 1-year

    CT or MR proof that the tumor relapse in the primary site by at least two radiologist.

Secondary outcomes

  1. Number of participants with abnormal laboratory values and/or adverse events that are related to the use of Denosumab(Xgeva)

    Time frame: at least 1-year

    include patient-reported adverse reactions, X-ray image of jawbone, serum calcium, alkaline phosphatase, renal and hepatic function, hemoglobin, white blood cell, and platelet count were collected in follow-up every 3-month.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Acronym: Deno-ABC

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 30, 2018
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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