alexa Randomized phase II trial of denosumab in patients with bone metastases from prostate cancer, breast cancer, or other neoplasms after intravenous bisphosphonates.
Clinical Research

Clinical Research

Journal of Clinical Trials

Author(s): Fizazi K, Lipton A, Mariette X, Body JJ

Abstract Share this page

PURPOSE: Patients with bone metastases and elevated urinary N-telopeptide (uNTx), representing excessive bone resorption, are at increased risk for skeletal-related events (SREs), cancer progression, and death. Osteoclast-mediated bone resorption is regulated by RANKL. We evaluated the effect of denosumab, a fully human monoclonal antibody against RANKL, in patients with bone metastases and elevated uNTx levels despite ongoing intravenous (IV) bisphosphonate (BP) therapy. PATIENTS AND METHODS: Eligible patients had histologically confirmed malignancy, > or = 1 bone metastases, and uNTx levels higher than 50 nmol/L bone collagen equivalents (BCE)/mM creatinine despite IV BPs. They were stratified by tumor type and screening uNTx levels (50 to 100 or > 100 nmol/L BCE/mM creatinine), and randomly assigned to continue IV BPs every 4 weeks or receive subcutaneous denosumab 180 mg every 4 weeks or every 12 weeks. RESULTS: Among 111 patients accrued, the primary end point of uNTx levels lower than 50 nmol/L BCE/mM creatinine (uNTx < 50) at week 13 was achieved by 49 (71%) of 69 patients in the denosumab arms, compared with 10 (29%) of 35 patients in the IV BP arm (P < .001). The proportion of patients with uNTx lower than 50 was maintained at week 25 (64% denosumab arms; 37% IV BP arm; P = .01). The incidence of SREs was six (8%) of 73 and six (17%) of 35 in the denosumab group and IV BP group, respectively. Rates of adverse events were similar between treatment groups. CONCLUSION: Among patients with elevated uNTx despite ongoing IV BP therapy, denosumab normalized uNTx levels more frequently than the continuation of IV BP. Fewer patients receiving denosumab experienced on-study SREs than those receiving IV BPs.

  • To read the full article Visit
  • Subscription
This article was published in Journal of clinical oncology and referenced in Journal of Clinical Trials

Relevant Expert PPTs

Relevant Speaker PPTs

Relevant Topics

Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

1-702-714-7001Extn: 9037

Business & Management Journals


1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

1-702-714-7001Extn: 9042

General Science

Andrea Jason

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

1-702-714-7001Extn: 9042

© 2008- 2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version