← Back to Search

Monoclonal Antibodies

Denosumab (Cohort A) for Giant Cell Tumor

Phase 4
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up length of study: through the earliest date of 5 years after signing the icf, death, withdrawal of consent, or lost to follow-up.
Awards & highlights

Study Summary

This trial will follow subjects who were treated in a previous trial for an additional 5 years to assess long-term safety.

Eligible Conditions
  • Giant Cell Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~length of study: through the earliest date of 5 years after signing the icf, death, withdrawal of consent, or lost to follow-up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and length of study: through the earliest date of 5 years after signing the icf, death, withdrawal of consent, or lost to follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of adverse events of interest in subjects with GCTB treated with denosumab
Secondary outcome measures
Rate of GCTB interventions for all subjects.
Rate of disease progression or recurrence of GCTB for all subjects.
Rate of serious adverse events for all subjects.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DenosumabExperimental Treatment1 Intervention
Cohort A (subjects who are still being treated with denosumab when 20062004 completes): 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). For subjects undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.
Group II: Safety Follow upActive Control1 Intervention
Subjects still receiving treatment will have follow-up study visits in the clinic every 6 months while receiving denosumab (Cohort A). Subjects who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit (Cohort B).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab (Cohort A)
2017
Completed Phase 4
~90

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,355 Previous Clinical Trials
1,383,986 Total Patients Enrolled
MDStudy DirectorAmgen
899 Previous Clinical Trials
921,663 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which ailments is Denosumab (Cohort A) typically prescribed?

"Patients with bone-related conditions such as skeletally mature and those exhibiting hormonal imbalances due to androgens can receive treatment from Denosumab (Cohort A)."

Answered by AI

What is the maximum number of participants allowed in this research study?

"This clinical trial is no longer searching for participants. It was originally posted in November 2017, with the last update being made in December 2021. If you are looking to join another study, there are presently 54 trials actively seeking patients with giant cell tumors of bone and 47 recruiting for Denosumab (Cohort A)."

Answered by AI

How many medical establishments are conducting this study?

"Currently, 10 medical sites are enrolling patients. Apart from Minneapolis, Philadelphia and Santa Monica, other locales include... It is advised to choose a trial center close to you so as to lessen commute requirements should you opt-in for the study."

Answered by AI

What other investigations have been performed on the efficacy of Denosumab (Cohort A)?

"Research on denosumab (Cohort A) was conducted at Xavier Nogues in 2016 with 110 studies completed. At present, there are 47 open clinical trials recruiting patients, primarily based out of Minneapolis, Minnesota."

Answered by AI

Has the FDA rendered a verdict on Denosumab (Cohort A) yet?

"The safety of Denosumab (Cohort A) has been established and is given a rating of 3 on the 1-3 scale used by Power, as it is currently approved for use in Phase 4 clinical trials."

Answered by AI

Is this research study open to new participants?

"This clinical trial is no longer accepting applicants, as reflected on the clinicaltrials.gov website; it was first posted in November 2017 and last updated in December 2021. Nevertheless, there are presently 101 separate studies that remain open to participants."

Answered by AI
~12 spots leftby Mar 2025