At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 6 enrolled

Drug / intervention

Denosumab (Xgeva)drug

Likely dose

Denosumab (Xgeva) 120 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03415477

NCT03415477Phase 2Completed

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Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts

Peking University People's Hospital·interventional·Posted Jan 30, 2018·Updated Jan 30, 2018

In Brief

A Phase 2 clinical trial evaluating Denosumab (Xgeva) for Bone Cyst Aneurysmal and 3 related conditions. Completed, enrolled 6 participants.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBone Cyst Aneurysmal, Pathological Fracture, Recurrent Disease, Refractory Tumor

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartJan 2014

Primary CompletionDec 2016

Study CompletionDec 2017

First PostedJan 2018

TodayJul 2026

First PostedJan 30, 2018

Enrollment StartJan 1, 2014

Primary CompletionDec 31, 2016

Study CompletionDec 31, 2017

TodayJul 2, 2026

Enrollment to primary: 3 yearsPosted 8.4 years ago

Interventions

Denosumab (Xgeva)drug

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.