Bone Modifying Agents for Breast and Prostate Cancer

Overseen By Marta Sienkiewicz

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Hospital Research Institute

Must be taking: BMA

Disqualifiers: Osteonecrosis, Hypercalcemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 48 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators propose is to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been on bone-modifying agents (BMA) for at least two years. It seems likely you will continue with BMA during the trial.

What data supports the effectiveness of the drug for treating bone issues in breast and prostate cancer?

Research shows that bone-modifying agents like bisphosphonates and denosumab can reduce bone complications by 25%-40% in advanced breast and prostate cancer. They also help prevent bone loss and improve survival in early-stage breast cancer, especially in postmenopausal women. ^{1 2 3 4 5}

What safety data exists for bone-modifying agents used in cancer treatment?

Bone-modifying agents, like bisphosphonates and denosumab, are widely used in cancer treatment, but they can cause side effects that may affect patients' quality of life. Experts have discussed managing these side effects to ensure safe use. A study also reviewed the safety of using these agents at different dosing intervals, highlighting the importance of monitoring for adverse events. ^{1 6 7 8 9}

How is the bone-modifying agent treatment different from other treatments for breast and prostate cancer?

Bone-modifying agents are unique because they specifically target bone health, reducing the risk of bone complications in patients with breast and prostate cancer that has spread to the bones. They help prevent bone loss and fractures, which is particularly important for patients experiencing bone metastases or treatment-induced bone loss. ^{1 2 4 10 11}

Research Team

Terry Ng, MD

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

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.

Inclusion Criteria

I have been on bone-modifying agents for over 2 years for bone metastases.

I have bone metastases from prostate or breast cancer and am receiving bone-modifying agents.

The following text is about someone who is able to provide verbal consent

Exclusion Criteria

Current hypercalcemia defined as corrected serum calcium of > 3 mmol/L (from standard bloodwork completed within one month prior to treatment dose)

I have or had bone disease in my jaw.

Definite contraindication for BMA

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either continuation or de-escalation of BMA treatment

48 weeks

Visits every 4, 12, or 24 weeks depending on treatment arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Bone Modifying Agent

Trial Overview 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.

Participant Groups

Group I: Standard BMA frequency Active Control 1 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 weeks Active Control 1 Intervention

Bone modifying agent once every 24 weeks.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Bone-Modifying Agents in Early-Stage and Advanced Breast Cancer. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Long-term impact of bone-modifying agents for the treatment of bone metastases: a systematic review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic management of metastatic bone disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Real-world use of bone modifying agents in metastatic, castration-resistant prostate cancer. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of bone-targeted agents on cancer progression and mortality. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Expert consensus on safety management of bone-modifying agents]. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of bone management agents administered at 12 weeks vs. 4 weeks in patients with bone metastases: A systematic review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Risk Factors for Developing Skeletal-Related Events in Breast Cancer Patients With Bone Metastases Undergoing Treatment With Bone-Modifying Agents. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacological Prevention and Management of Skeletal-Related Events and Bone Loss in Individuals with Cancer. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Perceptions around bone-modifying agent use in patients with bone metastases from breast and castration resistant prostate cancer: a patient survey. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Practical consensus recommendaton for adjuvant bone-modifying agents in breast cancer. [2020]