Zoledronic Acid in Preventing Osteoporosis in Patients Undergoing Donor Stem Cell Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2012

Conditions
LeukemiaLymphomaMyelodysplastic SyndromesOsteoporosisOvarian Cancer
Interventions
DIETARY_SUPPLEMENT

calcium

All randomized patients (control and study drug) will take 1000 mg of calcium and 400 - 500 International Units (IU) of vitamin D orally each day, beginning as soon as possible after study enrollment. These supplements may be taken either in the morning or in the evening with food. Participants will continue taking the supplements on a daily basis until the final study visit (approximately 12 months after the transplant date).

DIETARY_SUPPLEMENT

cholecalciferol

Given orally

DRUG

zoledronic acid

Zoledronic acid (Zometa®) will be administered after randomization (but within 28 days prior to transplant) and at 3 and 6 months after the transplant for a total of 3 doses. The dose of Zometa will be 4 mg intravenous in 100 ml of sterile 0.9% sodium chloride, United States Pharmacopeia (USP), or 5% dextrose, USP infused over a minimum of 15 minutes for patients with a calculated creatinine clearance of ≥60 mL/min. The drug may be administered through a peripheral or a central intravenous line.

Trial Locations (2)

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

53792-6164

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison

All Listed Sponsors
lead

University of Minnesota

OTHER

NCT00321932 - Zoledronic Acid in Preventing Osteoporosis in Patients Undergoing Donor Stem Cell Transplant | Biotech Hunter | Biotech Hunter