Neridronate prevents bone loss in patients receiving androgen deprivation therapy for prostate cancer

J Bone Miner Res. 2004 Nov;19(11):1766-70. doi: 10.1359/JBMR.040813. Epub 2004 Aug 23.

Abstract

Today, androgen deprivation therapy is a cornerstone of treatment for advanced prostate cancer, although it presents important complications such as osteoporosis. Neridronate, a relatively new bisphosphonate, is able to prevent bone loss in patients with prostate cancer during androgen ablation.

Introduction: Androgen-deprivation therapy (ADT) is a cornerstone of treatment for advanced prostate cancer. This therapy has iatrogenic complications, such as osteoporosis. The aim of our study was to evaluate the efficacy of neridronate, a relatively new bisphosphonate, to prevent bone loss during androgen ablation.

Materials and methods: Forty-eight osteoporotic patients with prostate cancer, treated with 3-month depot triptorelina, were enrolled and randomly assigned to two different treatment groups: group A (n = 24) was treated with a daily calcium and cholecalciferol supplement (500 mg of elemental calcium and 400 IU cholecalciferol), and group B (n = 24) received in addition to the same daily calcium and cholecalciferol supplement, 25 mg of neridronate given intramuscularly every month. All patients also received bicalutamide for 4 weeks. Lumbar and femoral BMD was evaluated by DXA at baseline and after 1 year of therapy; moreover, deoxypyridinoline (DPD) and bone alkaline phosphatase (BALP) were determined at the beginning, midway through, and at the end of the study.

Results: After 6 and 12 months, whereas patients treated only with calcium and cholecalciferol (group A) showed a marked bone loss, with increased levels of DPD and BALP compared with baseline values, patients treated also with neridronate (group B) had substantially unchanged levels of these markers. After 1 year of treatment, lumbar and total hip BMD decreased significantly in patients treated only with calcium and cholecalciferol (group A), whereas it did not change significantly at any skeletal site in patients treated also with neridronate (group B). No relevant side effects were recorded during our study.

Conclusions: Neridronate is an effective treatment in preventing bone loss in the hip and lumbar spine in men receiving ADT for prostate cancer.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Absorptiometry, Photon
  • Aged
  • Alkaline Phosphatase / metabolism
  • Amino Acids / therapeutic use
  • Androgen Antagonists / pharmacology
  • Androgens / metabolism*
  • Antineoplastic Agents, Hormonal / therapeutic use
  • Bone Density
  • Bone and Bones / drug effects
  • Calcium / blood
  • Calcium / therapeutic use
  • Cholecalciferol / therapeutic use
  • Diphosphonates / pharmacology*
  • Humans
  • Male
  • Osteoporosis / drug therapy
  • Prostatic Neoplasms / drug therapy*
  • Time Factors
  • Triptorelin Pamoate / therapeutic use

Substances

  • Amino Acids
  • Androgen Antagonists
  • Androgens
  • Antineoplastic Agents, Hormonal
  • Diphosphonates
  • Triptorelin Pamoate
  • Cholecalciferol
  • 6-amino-1-hydroxyhexane-1,1-diphosphonate
  • deoxypyridinoline
  • Alkaline Phosphatase
  • Calcium