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A Randomized Phase II of Zoledronic Acid (Zometa) in the Prevention of Osteoporosis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Phase 2
18 Years
Not Enrolling
Leukemia, Lymphoma, Myelodysplastic Syndromes, Osteoporosis, Ovarian Cancer

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Trial Information

A Randomized Phase II of Zoledronic Acid (Zometa) in the Prevention of Osteoporosis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation



- Evaluate whether prophylactic administration of zoledronic acid can reduce the severity
of bone mineral loss in patients undergoing allogeneic hematopoietic stem cell


- 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean Change in Bone Mineral Density

Outcome Description:

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.

Outcome Time Frame:

From Time of Transplant to 12 Months Post-Transplant

Safety Issue:


Principal Investigator

Linda J. Burns, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

March 2012

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Osteoporosis
  • Ovarian Cancer
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Osteoporosis
  • Ovarian Neoplasms



University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455