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Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts (Deno-ABC)

P

Peking University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Recurrent Disease
Pathological Fracture
Refractory Tumor
Bone Cyst Aneurysmal

Treatments

Drug: Denosumab (Xgeva)

Study type

Interventional

Funder types

Other

Identifiers

NCT03415477
Denosumab-ABC

Details and patient eligibility

About

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.

Full description

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.

Enrollment

6 patients

Sex

All

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

denosumab (Xgeva) treatment
Experimental group
Description:
Patients with aneurismal bone cysts received perioperative denosumab(Xgeva).
Treatment:
Drug: Denosumab (Xgeva)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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