Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts
Fjalë kyçe
Abstrakt
Përshkrim
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.
Datat
| Verifikuar së fundmi: | 12/31/2017 |
| Paraqitur së pari: | 01/09/2018 |
| Regjistrimi i vlerësuar u dorëzua: | 01/28/2018 |
| Postuar së pari: | 01/29/2018 |
| Përditësimi i fundit i paraqitur: | 01/28/2018 |
| Përditësimi i fundit i postuar: | 01/29/2018 |
| Data e fillimit të studimit aktual: | 12/31/2013 |
| Data e vlerësuar e përfundimit primar: | 12/30/2016 |
| Data e vlerësimit të përfundimit të studimit: | 12/30/2017 |
Gjendja ose sëmundja
Ndërhyrja / trajtimi
Drug: denosumab (Xgeva) treatment
Faza
Grupet e krahëve
| Krah | Ndërhyrja / trajtimi |
|---|---|
| Experimental: denosumab (Xgeva) treatment Patients with aneurismal bone cysts received perioperative denosumab(Xgeva). | Drug: denosumab (Xgeva) treatment 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. |
Kriteret e pranimit
| Moshat e pranueshme për studim | 12 Years Për të 12 Years |
| Gjinitë e pranueshme për studim | All |
| Pranon Vullnetarë të Shëndetshëm | po |
| Kriteret | Inclusion Criteria: 1. pathologically diagnosed with primary aneurysmal bone cyst 2. 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. 3. pathological fracture 4. recurrence cases Exclusion Criteria: 1. metastases or multi-focal lesions 2. malignancy |
Rezultati
Masat Kryesore të Rezultateve
1. Objective Response Rate (ORR) [at least 1-year]
2. local control rate [at least 1-year]
Masat dytësore të rezultateve
1. Number of participants with abnormal laboratory values and/or adverse events that are related to the use of Denosumab（Xgeva） [at least 1-year]
