NCT00219258CompletedPhase 3
A Randomized, Double-blind, Multi-centre Study to Evaluate the Fficacy and Safety of Zometa as a Treatment in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- To compare in a randomized fashion the effect of zoledronate and pamidronate 90 mg on pain relief as assessed by pain score after 1-dose treatment in patients with bone pain induced by any solid tumors with bone metastases or Multiple Myeloma
Study Overview
Brief Summary
Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other solid tumors with bone metastases.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cancer patients (multiple myeloma or other solid tumors) and confirmed evidence of bone lesions
- •Significant bone pain
Exclusion Criteria
- •Poor renal function
- •Use of other investigational drugs within 30 days of visit 2
- •Dental or other surgery to the jaw within 6 weeks of screening, or planned during the 4 week study
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
To compare in a randomized fashion the effect of zoledronate and pamidronate 90 mg on pain relief as assessed by pain score after 1-dose treatment in patients with bone pain induced by any solid tumors with bone metastases or Multiple Myeloma
Secondary Outcomes
- Changes in bone markers (urinary N-telopeptide/creatinine ratio, urinary C-telopeptide/creatinine ratio).
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 2
Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major PatientsBeta-ThalassemiaBone Marrow TransplantationNCT01016093Tehran University of Medical Sciences50
Completed
Phase 2
Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)Bone LossMuscle AtrophyBariatric SurgeryNCT04742010Stinus Gadegaard Hansen59
Completed
Phase 3
Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal TherapyBreast NeoplasmsOsteoporosisNCT00050011Novartis Pharmaceuticals602
Completed
Phase 3
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With OsteoporosisMale OsteoporosisNCT00439647Novartis Pharmaceuticals1,199
Completed
Phase 3
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With GlucocorticoidsOsteoporosisNCT00799266Novartis Pharmaceuticals34