Overview

Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants

Status:
Completed
Trial end date:
2012-04-03
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Diphosphonates
Zoledronic Acid
Criteria
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.