CompletedPhase 1/2

Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts

6 participantsStarted 2014-01-01

Plain-language 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.

Who can participate

Age range12 Years – 65 Years

SexALL

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Inclusion criteria

✓. pathologically diagnosed with primary aneurysmal bone cyst
✓. 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.
✓. pathological fracture
✓. recurrence cases

Exclusion criteria

✕. metastases or multi-focal lesions
✕. malignancy

What they're measuring

Objective Response Rate (ORR)

Timeframe: at least 1-year

local control rate

Timeframe: at least 1-year

Trial details

NCT IDNCT03415477

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-31

View on ClinicalTrials.gov More Bone Cyst Aneurysmal trials