Denosumab (Xgeva)
DrugDenosumab (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
NCT Number: NCT03415477
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.
Looking for future studies?
Notify Me12 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: at least 1-year
the number of participats (complete response+ partial response according to RECIST 1.1)/ total participants number.
Time frame: at least 1-year
CT or MR proof that the tumor relapse in the primary site by at least two radiologist.
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.
Peking University People's Hospital
Other
Acronym: Deno-ABC
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.
Published trials that share one or more normalized conditions with this study.
NCT03060096
Anxiety, Anxiety Disorders
Fort Smith, Arkansas, United States
View Trial DetailsNCT02564198
CNS Malignancies, Central Nervous System Neoplasms
Birmingham, Alabama, United States
View Trial DetailsNCT06024603
Disease Attributes, Neoplasms
Miami, Florida, United States
View Trial DetailsNCT03349450
Adult Diffuse Large Cell Lymphoma, Adult Refractory Diffuse Large B-Cell Lymphoma
Calgary, Alberta, Canada
View Trial Details