A Phase 1/2 interventional study of Denosumab (Xgeva) in Bone Cyst Aneurysmal, Pathological Fracture and Recurrent Disease, sponsored by Peking University People's Hospital. Completed. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-30.
Sponsored by Peking University People's Hospital · Phase 1/2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patients with aneurismal bone cysts received perioperative denosumab(Xgeva).
Drug: Denosumab (Xgeva)
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.
Also known as: surgical treatment
Objective Response Rate (ORR)
the number of participats (complete response+ partial response according to RECIST 1.1)/ total participants number.
Time frame: at least 1-year
local control rate
CT or MR proof that the tumor relapse in the primary site by at least two radiologist.
Time frame: at least 1-year
Number of participants with abnormal laboratory values and/or adverse events that are related to the use of Denosumab（Xgeva）
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.
Time frame: at least 1-year
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital