Clinical trial · Interventional
Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year
A Stratified, Randomized, Open-label, Multi-center Comparative 2-arm Trial of PK, PD, and Safety of Zoledronic Acid Infusions Administered Monthly vs. Every 3-month, in Multiple Myeloma Patients With Malignant Bone Lesions, and Breast Cancer Patients With Bone Metastasis, Who Have Received 9-12* Doses of Zoledronic Acid Over the Prior Year. (*Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines, the Title Has Not Been Changed)
- 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)
The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zometa q 4 weeks
- interventionNames
- Drug: Zoledronic acid
- type
- ACTIVE_COMPARATOR
- label
- Zometa q 12 weeks
- interventionNames
- Drug: Zoledronic acid
Primary outcomes (2)
- measure
- Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
- timeFrame
- every four (4) weeks
- measure
- Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female between 18-75 years of age * Multiple myeloma or breast cancer with bone involvement * Treatment with zoledronic acid for bone lesions between 10-15 months prior to entry into study with a total of 9-20 infusions received. Exclusion Criteria: * Current active dental problems or recent (within 8 weeks) or planned dental or jaw surgery * Active or uncontrolled infection, liver, or renal disease * History of treatment with intravenous bisphosphonates * Diagnosis of metabolic bone disorders other than osteoporosis (e.g. Paget's disease) Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available