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Zoledronic Acid for Chondrosarcoma

Q: Has the FDA sanctioned Zoledronic Acid for medicinal application?

Minimal clinical data exists to prove the efficacy and safety of Zoledronic Acid, so it was allocated a score of 1.

Q: Are there vacancies available for individuals who would like to participate in this experiment?

According to information made accessible on clinicaltrials.gov, this medical investigation is presently recruiting patients. The experiment was originally announced on July 18th 2017 and its particulars were edited as recently as August 21st 2022.

Q: What therapeutic application is Zoledronic Acid usually employed for?

Zoledronic acid is widely prescribed to address a range of malignant and benign conditions, including tumors, bone mineral density deficiencies, chemotherapy-induced symptoms, and <a href="https://www.withpower.com/clinical-trials/osteoporosis">osteoporosis</a>.

Q: Have there been prior explorations of Zoledronic Acid's potential in a clinical setting?

Currently, 36 medical trials are underway for Zoledronic Acid; 8 of these clinical studies are currently in their third phase. While the majority of experiments concerning this drug are held in Douliu, Yunlin County there exists a total 694 sites running related tests.

Q: How many research subjects are currently involved in this investigation?

Affirmative. Clinicaltrials.gov data points to the fact that this clinical trial, initiated on July 18th 2017 and updated lastly August 21st 2022, is presently recruiting participants. There are 20 spots open across a single medical facility.

Phase 1

Waitlist Available

Led By Mohammed Milhem, MBBS

Research Sponsored by Mohammed Milhem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status of </= 2

- Serum creatinine </= 1.5 x ULN or estimated creatinine clearance ≥ 50 ml/min by Cockcroft-Gault equation: GFR=(140-age)*(wt in kg)*(0.85 if female)/(72xCr)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all eligible patients that have initiated treatment will be considered evaluable for assessing overall survival up to 5 years.

Awards & highlights

Study Summary

This trial will study the effects of zoledronic acid on tumors in patients with resectable any grade chondrosarcoma.

Who is the study for?

This trial is for adults with any grade of resectable chondrosarcoma. Participants must have adequate blood counts, liver and kidney function, and not have used osteoclast inhibitors recently. Pregnant or breastfeeding women are excluded, as well as those with severe medical conditions or needing urgent dental surgery.Check my eligibility

What is being tested?

The study tests the effects of Zoledronic Acid on tumors in patients with chondrosarcoma before they undergo surgery. It's a phase 1b single-arm open-label trial, meaning all participants receive the same treatment without a comparison group.See study design

What are the potential side effects?

Zoledronic Acid may cause side effects such as fatigue, nausea, bone pain, fever-like symptoms shortly after infusion (flu-like syndrome), low calcium levels in the blood, and potential kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My kidney function is within the required range.

Select...

I have never taken zoledronic acid before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all eligible patients that have initiated treatment will be considered evaluable for assessing overall survival up to 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all eligible patients that have initiated treatment will be considered evaluable for assessing overall survival up to 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all eligible patients that have initiated treatment will be considered evaluable for assessing overall survival up to 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Expansion cohort: Response Rate - Change at evaluations

Phase 1b cohort: Dose Limiting Toxicity - to examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients

Secondary outcome measures

Overall survival

Recurrence (local or metastatic) free survival

Side effects data

From 2020 Phase 4 trial • 61 Patients • NCT03087851

90%

Infection (unspecified) + Musculoskeletal symptoms

40%

Flu-like symptoms after ZOL treatment

10%

Fracture

Cancer

100%

80%

60%

40%

20%

Study treatment Arm

9-months Group

Observation Group

6-month Group

Trial Design

1Treatment groups

Experimental Treatment

Group I: Zoledronic AcidExperimental Treatment1 Intervention

1 cycle of Zoledronic Acid (ZA) at 4mg IVP prior to surgery and a second cycle of ZA at 4 mg IVP 3 weeks after surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zoledronic Acid

2008

Completed Phase 4

~13830

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mohammed MilhemLead Sponsor

6 Previous Clinical Trials

127 Total Patients Enrolled

Varun Monga, MDLead Sponsor

6 Previous Clinical Trials

119 Total Patients Enrolled

Rising Tide FoundationOTHER

13 Previous Clinical Trials

4,210 Total Patients Enrolled

Media Library

Zoledronic Acid Clinical Trial Eligibility Overview. Trial Name: NCT03173976 — Phase 1

Chondrosarcoma Research Study Groups: Zoledronic Acid

Chondrosarcoma Clinical Trial 2023: Zoledronic Acid Highlights & Side Effects. Trial Name: NCT03173976 — Phase 1

Zoledronic Acid 2023 Treatment Timeline for Medical Study. Trial Name: NCT03173976 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned Zoledronic Acid for medicinal application?

"Minimal clinical data exists to prove the efficacy and safety of Zoledronic Acid, so it was allocated a score of 1."

Answered by AI

Are there vacancies available for individuals who would like to participate in this experiment?

"According to information made accessible on clinicaltrials.gov, this medical investigation is presently recruiting patients. The experiment was originally announced on July 18th 2017 and its particulars were edited as recently as August 21st 2022."

Answered by AI

What therapeutic application is Zoledronic Acid usually employed for?

"Zoledronic acid is widely prescribed to address a range of malignant and benign conditions, including tumors, bone mineral density deficiencies, chemotherapy-induced symptoms, and osteoporosis."

Answered by AI

Have there been prior explorations of Zoledronic Acid's potential in a clinical setting?

"Currently, 36 medical trials are underway for Zoledronic Acid; 8 of these clinical studies are currently in their third phase. While the majority of experiments concerning this drug are held in Douliu, Yunlin County there exists a total 694 sites running related tests."

Answered by AI

How many research subjects are currently involved in this investigation?

"Affirmative. Clinicaltrials.gov data points to the fact that this clinical trial, initiated on July 18th 2017 and updated lastly August 21st 2022, is presently recruiting participants. There are 20 spots open across a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anti-Osteoclast Therapy as Neoadjuvant in Treatment of Chondrosarcoma - Phase 1b Trial

Mohammed Milhem 2017. "Anti-Osteoclast Therapy as Neoadjuvant in Treatment of Chondrosarcoma - Phase 1b Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03173976.

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