title: Prospective Evaluation of Zoledronic Acid in the Treatment of Bone Metastases from Differentiated Thyroid Carcinoma.
abstract: OBJECTIVE
  The objectives of this study were to prospectively delineate the efficacy and safety of zoledronic acid for treating bone metastases (BM) from differentiated thyroid carcinoma (DTC), and to evaluate the relationships between levels of bone metabolic markers and occurrence of skeletal-related events (SREs).
  
  
  METHODS
  This was a prospective, single-arm, single-center study. Nineteen patients with BM from DTC were assigned to receive zoledronic acid therapy every 4-5 weeks. Imaging studies for sites of BM were conducted every 6 months, and levels of bone metabolic markers, including serum bone-specific alkaline phosphatase (BAP) and urinary N-telopeptide of type I collagen (NTx), were assessed every 3 months. To evaluate the efficacy of zoledronic acid use, data of SREs were compared with those of 16 historical controls.
  
  
  RESULTS
  SREs developed in eight patients (42 %), but metastatic spinal cord compression (MSCC) appeared in only one patient. Pain scores were ameliorated in five patients, but aggravated in six patients. Ten patients had stable disease, six showed progressive disease, and none showed partial or complete response during the observation period. Decreases in levels of bone metabolic markers were observed in ten patients for BAP and 15 for NTx. However, no significant correlations were identified between changes in bone metabolic marker levels and development of SREs.
  
  
  CONCLUSIONS
  Zoledronic acid may offer a mainstay of multidisciplinary treatment for patients with BM for the purpose of reducing SREs. Levels of serum BAP and urinary NTx do not appear reliable as indicators of amelioration of BM symptoms.
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan. y.orita@live.jp.
authors.forename: Yorihisa
authors.initials: Y
authors.lastname: Orita
authors.affiliation: Division of Endocrine Surgery, Department of Surgery, Nippon Medical School, Tokyo, Japan.
authors.forename: Iwao
authors.initials: I
authors.lastname: Sugitani
authors.affiliation: Department of Epidemiology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
authors.forename: Soshi
authors.initials: S
authors.lastname: Takao
authors.affiliation: Division of Head and Neck, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Toda
authors.affiliation: Division of Orthopedics, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Manabe
authors.affiliation: Division of Statistics, Genome Center of the Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Miyata
mesh_terms: D000328:Adult; D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood / Q000652:urine; D001859:Bone Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000556:secondary; D002277:Carcinoma / Q000150:complications / Q000188:drug therapy* / Q000556:secondary; D024042:Collagen Type I / Q000652:urine; D004164:Diphosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D010455:Peptides / Q000652:urine; D011446:Prospective Studies; D066066:Response Evaluation Criteria in Solid Tumors; D013117:Spinal Cord Compression / Q000209:etiology; D013964:Thyroid Neoplasms / Q000473:pathology*; D000077211:Zoledronic Acid
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D024042:Collagen Type I; D004164:Diphosphonates; D007093:Imidazoles; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D000077211:Zoledronic Acid; D000469:Alkaline Phosphatase