Bone Modifying Agents for Breast and Prostate Cancer

Not currently recruiting at 4 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of either continuing or reducing the frequency of bone-modifying agents (BMAs), which help manage bone-related complications, in breast and prostate cancer patients with bone metastases. The trial includes two groups: one will maintain the current BMA schedule, while the other will switch to less frequent doses. It seeks patients with breast or prostate cancer who have had bone metastases for at least two years and are currently receiving BMA treatment. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and it seeks to understand how it benefits more patients.

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 is the safety track record for bone modifying agents?

Research has shown that bone-modifying agents (BMAs), such as bisphosphonates and denosumab, have been used since 2007 to help patients with cancer that has spread to the bones, such as in breast and prostate cancer. These medications manage the condition by reducing complications related to cancer in the bones.

Studies indicate that about 60% of patients using BMAs for bone metastases experience some complications. However, these medications are generally well-tolerated. They are recommended to prevent serious bone problems in people with advanced cancer and have been a standard part of care for many years.

While some patients may still encounter bone-related issues, BMAs are considered safe enough for widespread use in treating bone metastases from cancers. This suggests a good level of confidence in their safety for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the impact of adjusting the frequency of bone-modifying agents (BMAs) for patients with breast and prostate cancer. Typically, BMAs are administered every 4 to 12 weeks to manage bone health. This trial investigates whether reducing the frequency to once every 24 weeks can still effectively maintain bone integrity while potentially minimizing side effects and treatment burden. By optimizing treatment intervals, this approach could enhance patient quality of life without compromising efficacy.

What evidence suggests that bone modifying agents are effective for bone metastases from breast and castration-resistant prostate cancer?

Research shows that bone-modifying agents (BMAs) effectively treat bone problems caused by breast and prostate cancer. In this trial, participants will join different treatment arms to evaluate BMA administration frequency. One arm will maintain the standard BMA frequency (every 4 or 12 weeks), while another will reduce BMA frequency to once every 24 weeks. Studies have found that administering BMAs every 24 weeks is as safe and effective as more frequent dosing, such as every 4 or 12 weeks. This indicates that even with less frequent doses, the treatment effectively manages bone health. Evidence suggests that extending the dosing intervals can be a viable option without affecting outcomes. Overall, these agents have proven helpful in managing bone-related issues in cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Terry Ng, MD

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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)

Definite contraindication for BMA

I have or had bone disease in my jaw.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04549207

Study Details | NCT04549207 | Comparing Continuation or ... A Randomised Trial Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6159799/

modifying agents for cancer patients with bone metastases ... There appears to be no difference in outcomes between 12-weekly de-escalated therapy and 4-weekly dosage regimen. The longer-interval dose is a better choice.

3. medpagetoday.com medpagetoday.com/meetingcoverage/esmo/118033

De-Escalating Bone-Modifying Therapy Safe, Effective in ... BERLIN -- Administering bone-modifying agents (BMAs) every 24 weeks after long-term use was a safe and effective strategy for patients with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2212137421000439

versus 12-weekly bone-targeted agent use in patients with ... We present the 2-year results of a randomised trial comparing 4- versus 12-weekly bone-targeting agents (BTAs) in patients with bone metastases from breast ...

5. aacrjournals.org aacrjournals.org/cancerres/article/82/4_Supplement/OT1-06-01/680224/Abstract-OT1-06-01-A-randomised-trial-comparing

A randomised trial comparing continuation or de-escalation of ... A randomised trial comparing continuation or de-escalation of bone modifying agents (BMA) in patients treated for over 2 years for bone metastases.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8140584/

Perceptions around bone-modifying agent use in patients ... Since starting BMA therapy, 104/172 (60%) patients reported bone metastases-related complications (83/137 [61%] of breast cancer and 21/35 [60%] ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.95

Real-world use of bone-modifying agents (BMA) in patients ... BMAs have been approved since 2007 and are recommended in mCRPC to prevent SSEs in pts with bone metastases or a high risk of osteoporotic fracture.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11646308/

Administration and cancer-control outcomes of bone ... Of all included patients with mCRPC with at least 1 bone metastasis, 60% (n = 251) received a bone-modifying agent vs 40% (n = 169) of patients without a bone- ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2816217

Bone-Modifying Agents in High-Risk Metastatic Castration ... Bone-modifying agents (BMAs) such as bisphosphonates and denosumab are effective in improving time to SRE in patients with metastatic castration ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2212137422000100

Real-world patient-reported outcomes of breast cancer or ... The PROBone registry study evaluated complaints and limitations caused by BM of breast and prostate cancer patients using patient-reported outcomes (PROs) in ...