Zoledronic acid for prevention of bone loss in patients receiving primary therapy for lymphomas: A prospective, randomized controlled phase III trial

Jason R. Westin, Michael A. Thompson, Vince D. Cataldo, Luis E. Fayad, Nathan Fowler, Michelle A. Fanale, Saatva Neelapu, Felipe Samaniego, Jorge Romaguera, Jatin Shah, Peter McLaughlin, Barbara Pro, Larry W. Kwak, Perpetua Sanjorjo, William A. Murphy, Camillo Jimenez, Bela Toth, Wenli Dong, Fredrick B. Hagemeister*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

Background: Patients with lymphoma are at risk of development of bone mineral density (BMD) loss from therapy with high-dose corticosteroids and alkylating agents. Zoledronic acid (ZA), a bisphosphonate, may prevent this complication of therapy. We evaluated the effect of ZA on the change in BMD and surrogate biomarkers in patients with lymphoma receiving initial chemotherapy. Patients and Methods: Our phase III trial randomized 74 patients with newly diagnosed lymphoma and a baseline BMD of ≥ -2.0 to receive oral calcium and vitamin D daily with or without ZA at enrollment and at 6 months after enrollment. BMD was evaluated at baseline and 1 year after enrollment. Secondary biomarker endpoints were collected at baseline and at 3, 6, 9, and 12 months after enrollment. Results: Forty-three percent of patients had baseline osteopenia. Fifty-three patients were evaluable for response: 24 received ZA and had stable BMD during the observation period, whereas 29 patients in the control group had decreased BMD (P <.05 at lumbar spine and bilateral femoral neck). Twenty-one randomized patients were not evaluable for response because of lymphoma progression or death, withdrawn consent/incomplete testing, or ineligibility. Bone biomarkers were higher in the control group at all intervals after treatment (P <.001). No fractures or intervention-related toxicities were observed during this trial. Conclusions: Newly diagnosed patients with lymphoma are at risk of low BMD, which may worsen with therapy. Treatment with ZA effectively stabilizes BMD and prevents bone loss. Our data suggest that BMD testing and prophylaxis should be considered as an early intervention for a preventable problem.

Original languageEnglish (US)
Pages (from-to)99-105
Number of pages7
JournalClinical Lymphoma, Myeloma and Leukemia
Volume13
Issue number2
DOIs
StatePublished - Apr 2013

Keywords

  • Bone density
  • Bone loss
  • Calcium
  • Lymphoma
  • Newly diagnosed
  • Osteopenia
  • Osteoporosis
  • Vitamin D
  • Zoledronic acid

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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