Clinical trial · Interventional
Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients
A Phase IV, Multi-center, Open Label, Single Arm Clinical Trial to Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients
NCT00912938CI-TRIAL-00003154unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
to evaluate whether bone marker can provide the valuable predictor of skeletal complications and whether regular assessing of NTX(N-telopeptide of type I collagen) and osteocalcin can be useful in advanced breast cancer patients with bone metastasis receiving zoledronic acid.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zoledronic acid
- description
- Patients with advanced breast cancer with radiographic confirmation of bone metastases. This arm will be receiving zoledronic acid administration. The primary endpoint is to find the correlation between bone turnover markers and the frequency of skeletal-related-events for one year. Skeletal related events are defined as pathologic fractures, the need for radiation therapy, orthopaedic surgery, hypercalcemia of malignancy and spinal cord compression. A total of 237 patients will be included.
- interventionNames
- Drug: zoledronic acid
Primary outcomes (1)
- measure
- Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected.
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with advanced breast cancer with radiographic confirmation of bone metastases (minimum of one bone scan lesion must be confirmed as metastatic on plain radiographs or CT/MR imaging) 2. Men or women aged ≥ 18 years 3. WHO (ECOG) performance status 0-2 4. Women of child-bearing potential must be using a reliable and appropriate method of contraception 5. Urine sample taken and sent to the central laboratory for baseline Ntx analysis 6. Written informed consent. Exclusion Criteria: 1. Bisphosphonate treatment within the 4 weeks prior to planned first study treatment 2. Abnormal renal function as evidenced by a calculated creatinine clearance \< 30 ml/minute 3. Poor venous access 4. Metabolic bone disease 5. Unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements 6. Estimated life expectancy of \< 6 months 7. Treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry 8. Wide field (hemi-body) radiotherapy within the 3 months prior to study entry 9. Concomitant medication with drugs known to affect bone metabolism 10. Pregnancy or breast-feeding 11. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular), or a current or prior diagnosis of osteonecrosis of the jaw (ONJ) 12. Recent (within 4 weeks of study entry\*) or planned dental or jaw surgery
References
Publications (0)
Data not yet available
No reference posted for this study.