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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
Sponsor:
Information provided by (Responsible Party):
GUO WEI, Peking University People's Hospital

Brief Summary:
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

Detailed 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.

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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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
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 :
  1. 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.

  2. 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 :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications:
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Responsible Party: GUO WEI, Director, Head of Muscoloskeletal Tumor Center, Principal Investigator, Clinical Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03415477     History of Changes
Other Study ID Numbers: Denosumab-ABC
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by GUO WEI, Peking University People's Hospital:
aneurysmal bone cyst, denosumab, surgical treatment, complication

Additional relevant MeSH terms:
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Bone Cysts
Bone Cysts, Aneurysmal
Neoplasms
Bone Diseases
Fractures, Bone
Bone Density Conservation Agents
Cysts
Fractures, Spontaneous
Pathological Conditions, Anatomical
Musculoskeletal Diseases
Wounds and Injuries
Denosumab
Physiological Effects of Drugs