Breast Cancer study: Romosozumab
Official title A Study of Romosozumab in People With Breast Cancer and Osteoporosis
ClinicalTrials.gov ID: NCT07776613
What this study is testing
What is Romosozumab?
Romosozumab is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if romosozumab can increase bone formation and is safe for people whose breast cancer has spread to bone and who have osteoporosis.
- Who it's for
- Adults with metastatic breast cancer that has spread to bone and who also have osteoporosis.
- What's involved
- Participants will receive romosozumab injections and undergo tests to measure bone formation and breakdown.
- Time commitment
- The study lasts for several months with regular clinic visits for injections and bone assessments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- ≥18 years of age at the time of giving informed consent;
- Patients diagnosed with hormone-receptor positive (ER/PR \>1%) metastatic breast cancer to bones on any endocrine therapy with or without targeted...
- osteoporosis on dual X-ray absorptiometry (DXA) scan; or history of fragility fracture of the spine or hip; or of morphometric spine fracture;
You likely can't join if
- Prior therapy with a bone-modifying agent (intraveous bisphosphonates or subcutaneous denosumab) for metastatic bone disease;
- 25 (OH) vitamin D levels \< 20 ng/mL; Vitamin D repletion will be permitted and people will be be rescreened once 25 (OH) vitamin D level ³ 20 ng/mL;
- History of myocardial infarction or stroke within the preceding year;
- Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range per institutional standard (\ 10.5 mg/dL)
- History of non-healed dental or oral surgery;
- History of osteonecrosis of the jaw
The study team makes the final eligibility decision.
Where it is enrolling
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.