Journal ArticleDOI
Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial--the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group.
Lee S. Rosen,David Gordon,Simon Tchekmedyian,Ronald Yanagihara,Vera Hirsh,Maciej Krzakowski,Marek Pawlicki,Paul de Souza,Ming Zheng,Gladys Urbanowitz,Dirk J. Reitsma,John J. Seaman +11 more
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TLDR
Zoledronic acid (4 mg infused over 15 minutes) is the first bisphosphonate to reduce skeletal complications in patients with bone metastases from solid tumors other than breast and prostate cancer.Abstract:
Purpose: To assess the efficacy and safety of zoledronic acid in patients with bone metastases secondary to solid tumors other than breast or prostate cancer. Patients and Methods: Patients were randomly assigned to receive zoledronic acid (4 or 8 mg) or placebo every 3 weeks for 9 months, with concomitant antineoplastic therapy. The 8-mg dose was reduced to 4 mg (8/4-mg group). The primary efficacy analysis was proportion of patients with at least one skeletal-related event (SRE), defined as pathologic fracture, spinal cord compression, radiation therapy to bone, and surgery to bone. Secondary analyses (time to first SRE, skeletal morbidity rate, and multiple event analysis) counted hypercalcemia as an SRE. Results: Among 773 patients with bone metastases from lung cancer or other solid tumors, the proportion with an SRE was reduced in both zoledronic acid groups compared with the placebo group (38% for 4 mg and 35% for 8/4 mg zoledronic acid v 44% for the placebo group; P = .127 and P = .023 for 4-mg an...read more
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Journal ArticleDOI
Clinical Features of Metastatic Bone Disease and Risk of Skeletal Morbidity
TL;DR: Improved understanding of prognostic and predictive factors may enable delivery of a more personalized treatment for the individual patient and a more cost-effective use of health care resources.
Journal ArticleDOI
Osteonecrosis of the Jaw in Cancer After Treatment With Bisphosphonates: Incidence and Risk Factors
Aristotle Bamias,Efstathios Kastritis,Christina Bamia,Lia A. Moulopoulos,Ioannis Melakopoulos,George Bozas,Vassiliki Koutsoukou,Dimitra Gika,Athanasios Anagnostopoulos,Christos Papadimitriou,Evagelos Terpos,Meletios A. Dimopoulos +11 more
TL;DR: The type of bisphosphonate may play a role and previous dental procedures may be a precipitating factor for this complication and length of exposure seems to be the most important risk factor.
Journal ArticleDOI
Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial.
Lee S. Rosen,David Gordon,Mary Kaminski,Anthony Howell,Andrew R. Belch,John R. Mackey,J. Apffelstaedt,Mohamad A. Hussein,Robert E. Coleman,Dirk J. Reitsma,Bee-Lian Chen,John J. Seaman +11 more
TL;DR: In this article, the authors compared the long-term safety and efficacy of zoledronic acid with pamidronate in patients with bone lesions secondary to advanced breast carcinoma or multiple myeloma.
Journal ArticleDOI
Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial.
Lee S. Rosen,David Gordon,N. Simon Tchekmedyian,Ronald Yanagihara,Vera Hirsh,Maciej Krzakowski,Marek Pawlicki,Paul de Souza,Ming Zheng,Gladys Urbanowitz,Dirk J. Reitsma,John J. Seaman +11 more
TL;DR: The long‐term efficacy and safety of 21 months of treatment with zoledronic acid in a randomized, placebo‐controlled trial are reported.
Journal ArticleDOI
Frequency and Risk Factors Associated With Osteonecrosis of the Jaw in Cancer Patients Treated With Intravenous Bisphosphonates
Ana O. Hoff,Bela B. Toth,Kadri Altundag,Marcella M. Johnson,Carla L. Warneke,Mimi Hu,Ajay K. Nooka,Gilbert Sayegh,Valentina Guarneri,Kimberly Desrouleaux,Jeffrey Cui,Andrea Adamus,Robert F. Gagel,Gabriel N. Hortobagyi +13 more
TL;DR: Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates and the incidence and risk factors associated with this disorder have not been clearly defined.
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Journal ArticleDOI
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