Trial record 68 of 4295 for: bone tumors AND NOT metastatic
Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts (Deno-ABC)
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|ClinicalTrials.gov Identifier: NCT03415477|
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Peking University People's Hospital
Information provided by (Responsible Party):
GUO WEI, Peking University People's Hospital
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.
|Condition or disease||Intervention/treatment||Phase|
|Bone Cyst Aneurysmal Pathological Fracture Recurrent Disease Refractory Tumor||Drug: Denosumab (Xgeva)||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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with recurrent and/or refractory aneurysmal bone cysts treated with denosumab perioperatively.|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts|
|Actual Study Start Date :||January 1, 2014|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2017|
Experimental: denosumab (Xgeva) treatment
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.
Other Name: surgical treatment
Primary Outcome Measures :
- 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.
- 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 Outcome Measures :
- 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.
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