Clinical trial · Interventional
Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts
NCT03415477CI-TRIAL-00031430Deno-ABCcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Cyst Aneurysmal | Aneurysmal Bone Cyst | ALIAS | 0.90 |
| Pathological Fracture | — | UNRESOLVED | — |
| Recurrent Disease | — | UNRESOLVED | — |
| Refractory Tumor | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Denosumab (Xgeva) | Drug | Denosumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- denosumab (Xgeva) treatment
- description
- Patients with aneurismal bone cysts received perioperative denosumab(Xgeva).
- interventionNames
- Drug: Denosumab (Xgeva)
Primary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- at least 1-year
- description
- the number of participats (complete response+ partial response according to RECIST 1.1)/ total participants number.
- measure
- local control rate
- timeFrame
- at least 1-year
- description
- CT or MR proof that the tumor relapse in the primary site by at least two radiologist.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDGhermandi R, Terzi S, Gasbarrini A, Boriani S. Denosumab: non-surgical treatment option for selective arterial embolization resistant aneurysmal bone cyst of the spine and sacrum. Case report. Eur Rev Med Pharmacol Sci. 2016 Sep;20(17):3692-5. PMID 27649673
- BACKGROUNDDubory A, Missenard G, Domont J, Court C. Interest of Denosumab for the Treatment of Giant-cells Tumors and Aneurysmal Bone Cysts of the Spine. About Nine Cases. Spine (Phila Pa 1976). 2016 Jun;41(11):E654-E660. doi: 10.1097/BRS.0000000000001350. PMID 27244112
- BACKGROUNDSkubitz KM, Peltola JC, Santos ER, Cheng EY. Response of Aneurysmal Bone Cyst to Denosumab. Spine (Phila Pa 1976). 2015 Nov;40(22):E1201-4. doi: 10.1097/BRS.0000000000001027. PMID 26730528
- BACKGROUNDPauli C, Fuchs B, Pfirrmann C, Bridge JA, Hofer S, Bode B. Response of an aggressive periosteal aneurysmal bone cyst (ABC) of the radius to denosumab therapy. World J Surg Oncol. 2014 Jan 20;12:17. doi: 10.1186/1477-7819-12-17. PMID 24438319