Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321932
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2006-05-02
Brief Title:
Zoledronic Acid in Preventing Osteoporosis in Patients Undergoing Donor Stem Cell Transplant
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
A Randomized Phase II of Zoledronic Acid Zometa in the Prevention of Osteoporosis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Zoledronic acid vitamin D and calcium may prevent bone loss in patients who are undergoing donor stem cell transplant
PURPOSE This randomized phase II trial is studying how well zoledronic acid works in preventing osteoporosis in patients undergoing donor stem cell transplant
PURPOSE This randomized phase II trial is studying how well zoledronic acid works in preventing osteoporosis in patients undergoing donor stem cell transplant
Detailed Description:
OBJECTIVES
Primary
Evaluate whether prophylactic administration of zoledronic acid can reduce the severity of bone mineral loss in patients undergoing allogeneic hematopoietic stem cell transplantation
Secondary
Determine the safety of zoledronic acid in these patients
OUTLINE This is a multicenter open-label prospective randomized controlled study Patients are stratified according to participating center and type of transplant myeloablative vs nonmyeloablative Patients are randomized to 1 of 2 treatment arms
Arm I control Patients receive oral cholecalciferol vitamin D and oral calcium once a day for 12 months
Arm II treatment Patients receive vitamin D and calcium as in arm I Patients also receive zoledronic acid intravenously IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation
In both arms treatment continues in the absence of unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 12 months
Primary
Evaluate whether prophylactic administration of zoledronic acid can reduce the severity of bone mineral loss in patients undergoing allogeneic hematopoietic stem cell transplantation
Secondary
Determine the safety of zoledronic acid in these patients
OUTLINE This is a multicenter open-label prospective randomized controlled study Patients are stratified according to participating center and type of transplant myeloablative vs nonmyeloablative Patients are randomized to 1 of 2 treatment arms
Arm I control Patients receive oral cholecalciferol vitamin D and oral calcium once a day for 12 months
Arm II treatment Patients receive vitamin D and calcium as in arm I Patients also receive zoledronic acid intravenously IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation
In both arms treatment continues in the absence of unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-0506M70866 | OTHER | None | None |
| UMN-MT2005-06 | OTHER | None | None |
| NOVARTIS-CZOL446EUS29 | OTHER | Novartis | None |