A Study of Romosozumab in People With Breast Cancer and Osteoporosis

A Phase II Study Evaluating the Efficacy and Safety of Romosozumab as a Bone-Modifying Agent in Patients With Metastatic Breast Cancer to Bones and Osteoporosis With High Fracture Risk (REMOLD-Breast)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07776613

Enrollment

Registered

2026-08-20

Start date

2026-08-17

Completion date

2028-08-01

Last updated

2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Metastatic Breast Cancer (MBC)

Keywords

Romosozumab, 26-191

Brief summary

The researchers are doing this study to see if romosozumab is effective at helping with bone formation in people with metastatic breast cancer (MBC) that has spread to the bones. All participants will have osteoporosis. The researchers will also look at bone breakdown (resorption) in participants and determine if romosozumab is a safe treatment for osteoporosis in people with MBC that has spread to the bones.

Interventions

DRUGRomosozumab

Romosozumab will be given on-label at 210 mg administered SC once monthly for 12 months.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

This is a phase II single arm study.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥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 therapy (i.e. CDK 4/6 inhibitors, PI3K inhibitors, anti-HER2-therapy); * Evidence of osteoporosis on dual X-ray absorptiometry (DXA) scan; must following: * osteoporosis on dual X-ray absorptiometry (DXA) scan; or history of fragility fracture of the spine or hip; or of morphometric spine fracture;

Exclusion criteria

* 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 subjects 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 (\<8.5 or \>10.5 mg/dL); Calcium repletion will be permitted and subjects will be be rescreened once values are within the institutional standard. * History of non-healed dental or oral surgery; * History of osteonecrosis of the jaw

Design outcomes

Primary

Measure	Time frame	Description
Percent change in Procollagen Type 1 N-telopeptide (P1NP ) levels	1 year	Blood samples for the panel of bone turnover markers

Countries

United States

Contacts

CONTACTMonica Fornier, MD

fornierm@mskcc.org646-888-5240

CONTACTJasmeet Singh, MD

914-367-7358

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026