Intermittent zoledronic acid prevents bone loss in adults after allogeneic hematopoietic cell transplantation

Parameswaran Hari, Todd E. DeFor, David H. Vesole, Christopher N. Bredeson, Linda J. Burns

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

Abstract

Bone mineral density (BMD) loss is common in survivors of allogeneic hematopoietic cell transplantation (alloHCT). We performed a multicenter, phase II, randomized open-label trial of intravenous zoledronic acid (ZA) to prevent BMD loss in adult recipients of alloHCT with osteopenia before HCT. The treatment group received ZA 4 mg intravenously within 28 days pre-HCT and at 3 and 6 months after HCT. Both treatment and control groups received calcium carbonate and vitamin D supplements. Of 61 patients, 32 were randomized to the ZA cohort and 29 to the control cohorts. More patients in the ZA group had an HCT comorbidity index high-risk score of ≥3 (50% versus 21%, P < .01). Baseline BMD, T-scores, serum osteocalcin, bone alkaline phosphatase, and urine N-telopeptide (UNTX) levels were similar in both cohorts. Thirty patients were evaluable for outcomes (11 from the treatment and 19 from the control group). At 12 months, subjects in the treatment group had an improvement in BMD at the femoral neck (mean change, .018 for ZA group versus-.054 for controls; P= .04) and a significant decline in levels of UNTX (-56 for ZA group versus-9 for control; P= .04) compared with baseline. ZA was well tolerated and not associated with any cases of osteonecrosis of jaw or renal impairment. Lower survival observed in the ZA cohort was likely related to baseline imbalance in HCT-CI scores. Intermittent ZA is effective in preserving long-term bone health in adult alloHCT recipients at risk for osteoporosis.

Original languageEnglish (US)
Pages (from-to)1361-1367
Number of pages7
JournalBiology of Blood and Marrow Transplantation
Volume19
Issue number9
DOIs
StatePublished - Sep 2013

Bibliographical note

Funding Information:
We thank the patients and their families, as well as the medical and nursing staffs at the Medical College of Wisconsin and the University of Minnesota for their dedication and support. We also thank Judy Witte and Marilee Larkin at the University of Minnesota and Sharon Vine and Deborah Pastorek at the Medical College of Wisconsin for data collection and management. Zoledronic acid for this study and a portion of patient care costs was provided by Novartis Pharmaceuticals Corporation. The work was also supported by the Janie Lymphoma Fund (L.J.B.).

Keywords

  • Allogeneic hematopoietic cell
  • Bisphosphonates
  • Osteoporosis
  • Transplantation
  • Zoledronic acid

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