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Bone Modifying Agent

Bone Modifying Agents for Breast and Prostate Cancer

Phase 4
Recruiting
Led By Terry Ng, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Patient has received BMA for 2 or more years counting from the first BMA dose for bone metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks after randomization (one year of treatment)
Awards & highlights

Study Summary

This trial will compare continuing or further reducing bone metastases treatment after two years in patients with breast or prostate cancer.

Who is the study for?
This trial is for adults over 18 with bone metastases from breast or castration-resistant prostate cancer, who have been on bone modifying agents (BMAs) for at least two years. It's not suitable for those with high calcium levels, contraindications to BMA, jawbone issues, or upcoming bone surgery/radiotherapy within a month.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of either continuing or reducing the dosage of BMAs after two years of treatment in patients with certain types of cancer that has spread to bones. Participants will be randomly assigned to one of these two approaches.See study design
What are the potential side effects?
While specific side effects are not listed here, BMAs can generally cause issues like flu-like symptoms, low calcium levels in blood, digestive problems, and rarely conditions such as osteonecrosis of the jaw.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been on bone-modifying agents for over 2 years for bone metastases.
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I have bone metastases from prostate or breast cancer and am receiving bone-modifying agents.
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I have been on bone-modifying agents for over 2 years for bone metastases.
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I have bone metastases from prostate or breast cancer and am on bone-modifying agents.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks after randomization (one year of treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks after randomization (one year of treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Health related quality of life scores
Secondary outcome measures
BMA-related toxicity rates
Incremental cost-effectiveness rations
Quality of life of cancer patients using the EORTC-QLQ-BM22
+5 more
Other outcome measures
Frequency of restarting standard dosing BMA
Frequency of subsequent de-escalation or discontinuation of BMAs
Overall survival

Trial Design

2Treatment groups
Active Control
Group I: Standard BMA frequencyActive Control1 Intervention
Continue standard BMA frequency (every 4 or 12 weeks) as administered previously. If a change in BMA frequency (every 4 weeks to every 12 weeks OR every 12 weeks to every 4 weeks) was prescribed by the physician, this would still be considered on protocol treatment.
Group II: De-escalate BMA to once every 24 weeksActive Control1 Intervention
Bone modifying agent once every 24 weeks.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,451 Total Patients Enrolled
3 Trials studying Prostate Cancer
375 Patients Enrolled for Prostate Cancer
Terry Ng, MDPrincipal InvestigatorOttawa Hospital Research Institute
1 Previous Clinical Trials
233 Total Patients Enrolled

Media Library

Bone Modifying Agent (Bone Modifying Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04549207 — Phase 4
Prostate Cancer Research Study Groups: Standard BMA frequency, De-escalate BMA to once every 24 weeks
Prostate Cancer Clinical Trial 2023: Bone Modifying Agent Highlights & Side Effects. Trial Name: NCT04549207 — Phase 4
Bone Modifying Agent (Bone Modifying Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04549207 — Phase 4

Frequently Asked Questions

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

What use cases tend to involve Standard BMA frequency treatment?

"Standard BMA frequency is an approved treatment for malignant neoplasms, osteoporosis, and males with low bone mineral density."

Answered by AI

Are there any remaining opportunities to enroll in this research endeavor?

"Affirmative. Clinicaltrials.gov's records show that this research project is presently recruiting participants, beginning from October 9th 2020 and last updated on April 19th 2022. This trial requires the enrolment of 240 people at a single medical centre."

Answered by AI

Has research been conducted that has explored Standard BMA frequency previously?

"Presently, 76 clinical trials are actively examining the efficacy of Standard BMA frequency; 20 of which have progressed to Phase 3. Though many studies for this procedure originate from Douliu in Yunlin County, there remain 1147 sites where clinical investigations into its effects are ongoing."

Answered by AI

How many participants have been recruited for this clinical research program?

"Affirmative. According to the information on clinicaltrials.gov, this study is actively looking for volunteers and was first posted in October of 2020. It has most recently been updated in April of 2022 with a goal of enrolling 240 people at one site."

Answered by AI

Has the FDA authorized the use of Standard BMA frequency?

"There is ample evidence to suggest that this treatment, Standard BMA frequency, has been approved and thus earned a score of 3."

Answered by AI
~35 spots leftby Nov 2024