NCT00622505
Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants
PHASE4
COMPLETED
NCT00622505
INTERVENTIONAL
Bone Marker-directed Dosing of ZOMETA® (Zoledronic Acid) for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma.
This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.
Inclusion Criteria:
* Confirmed diagnosis of multiple myeloma
* Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma
* Stable renal function
Exclusion Criteria:
* Known sensitivity to bisphosphonates
* Receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover
* Current active dental problems
* Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment
Other protocol-defined inclusion/exclusion criteria may apply.
Multiple Myeloma
- PREVENTION
-
- Type: DRUG
- Name: zoledronic acid
- Description: Zoledronic acid concentrate (4 mg/5 milliliters \[ml\]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks.
- Arm Group Labels: Zoledronic acid
- Novartis Pharmaceuticals