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Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts

NCT00459641 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-07-17

No results posted yet for this study

Summary

This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst.

Conditions

  • Bone Cysts

Interventions

DRUG

I-040302

doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34

OTHER

Standard of Care

Bone marrow aspirate or steroids

Sponsors & Collaborators

  • Kuros Biosurgery AG

    lead INDUSTRY

Principal Investigators

  • Virginia Jamieson, MD · Kuros Biosurgery AG, Technoparkstrasse 1, CH-8005 Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-06-30
Completion
2019-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00459641 on ClinicalTrials.gov