NCT00321932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Jul 2005

Typical duration for phase_2 leukemia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 26, 2012

Completed
Last Updated

March 9, 2017

Status Verified

January 1, 2017

Enrollment Period

5.7 years

First QC Date

May 2, 2006

Results QC Date

May 4, 2012

Last Update Submit

January 26, 2017

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesOsteoporosisOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Bone Mineral Density

    Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months. This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline.

    From Time of Transplant to 12 Months Post-Transplant

Secondary Outcomes (8)

  • Mean Change in Serum Osteocalcin

    From Time of Transplant to 12 Months Post-Transplant

  • Mean Change in Serum Bone Specific Alkaline Phosphate

    From Time of Transplant to 12 Months Post-Transplant

  • Mean Change in Urinary N-terminal Telopeptide

    From Time of Transplant to 12 Months Post-Transplant

  • Mean Change in Luteinizing Hormone

    From Time of Transplant to 12 Months Post-Transplant

  • Mean Change in Follicle-Stimulating Hormone

    From Time of Transplant to 12 Months Post-Transplant

  • +3 more secondary outcomes

Study Arms (2)

Arm I (control)

ACTIVE COMPARATOR

Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.

Dietary Supplement: calciumDietary Supplement: cholecalciferol

Arm II (treatment)

EXPERIMENTAL

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.

Dietary Supplement: calciumDietary Supplement: cholecalciferolDrug: zoledronic acid

Interventions

calciumDIETARY_SUPPLEMENT

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).

Also known as: calcium carbonate, calcium citrate, calcium gluconate
Arm I (control)Arm II (treatment)
cholecalciferolDIETARY_SUPPLEMENT

Given orally

Arm I (control)Arm II (treatment)
zoledronic acidDRUG

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.

Also known as: Zometa(R)
Arm II (treatment)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age ≥18 years
  • Undergoing allogeneic hematopoietic stem cell transplantation (HCT) from any stem cell source with either a myeloablative or non-myeloablative conditioning regimen
  • Bone mineral density measured by baseline pre-transplant DEXA scan in the osteopenic range (defined as a T-score between -1 and -2.5 standard deviation (SD) at either the lumbar spine or the proximal femur or both)
  • Adequate renal function defined as: Calculated creatinine clearance of ≥ 60 ml/min using the Cockcroft-Gault formula:
  • Serum calcium (corrected) of ≤ 10.5 mg/dl
  • Patients (male or female) of reproductive potential are required to use a medically acceptable contraception while receiving zoledronic acid (if assigned study drug).
  • Normal dental exam within the year prior to study registration
  • Informed signed consent to participate in the study

You may not qualify if:

  • Pre-existing metabolic bone disease including osteomalacia, hyperparathyroid bone disease, osteogenesis imperfecta, Paget's disease, rickets, or hypoparathyroidism.
  • Multiple myeloma
  • History of nontraumatic vertebral compression fractures
  • History of the following endocrine disorders - hyperparathyroidism, hyperthyroidism.
  • Malabsorption syndrome including Crohn's disease.
  • Chronic liver disease
  • Concomitant regular use of phenytoin.
  • Known hypersensitivity to zoledronic acid (Zometa) or other biphosphonates
  • Biphosphonate therapy within the preceding six months.
  • Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
  • Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
  • Not pregnant or breastfeeding since zoledronic acid is classified as Pregnancy Category C: risk in pregnancy cannot be ruled out. A negative pregnancy test is required within 7 days of registration if pre- or perimenopausal (i.e., last menstrual period within one year of registration). Because it is not known whether zoledronic acid is excreted in breast milk, breastfeeding is not permitted while receiving study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesOsteoporosisOvarian Neoplasms

Interventions

CalciumCalcium CarbonateCalcium CitrateCalcium GluconateCholecalciferolZoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsCalcium CompoundsCarbonatesCarbonic AcidCarbon Compounds, InorganicMineralsCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsGluconatesSugar AcidsHydroxy AcidsCarbohydratesCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Linda Burns, M.D.
Organization
Masonic Cancer Center, University of Minnesota
burns023@umn.edu
612-624-8144

Study Officials

  • Linda J. Burns, MD

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 4, 2006

Study Start

July 1, 2005

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

March 9, 2017

Results First Posted

October 26, 2012

Record last verified: 2017-01

Locations

US(2)