ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 1795

Denosumab Restores Cortical Bone Loss at the Distal Radius Associated with Aging and Reduces Wrist Fracture Risk: Analyses from the Cross-over Group in the Extension of the Denosumab Pivotal Fracture Trial

JP Bilezikian1, CL Benhamou2, CJF Lin3, JP Brown4, NS Daizadeh3, PR Ebeling5, A Fahrleitner-Pammer6, E Franek7, N Gilchrist8, PD Miller9, JA Simon10, I Valter11, CAF Zerbini12 and C Libanati3, 1College of Physicians and Surgeons, Columbia University, New York, NY, 2CHR d'Orléans, Orléans, France, 3Amgen Inc., Thousand Oaks, CA, 4CHU de Québec Research Centre and Laval University, Quebec City, QC, Canada, 5Monash University, Clayton, Australia, 6Medical University, Graz, Austria, 7Medical Research Center, Polish Academy of Sciences, Warsaw, Poland, 8The Princess Margaret Hospital, Christchurch, New Zealand, 9Colorado Center for Bone Research, Lakewood, CO, 10George Washington University, Washington, DC, 11Center for Clinical and Basic Research, Tallinn, Estonia, 12Centro Paulista de Investigação Clinica, São Paulo, Brazil

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Bone density, denosumab, fracture risk and osteoporosis

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Title: ACR Plenary Session II: Discovery 2014

Session Type: Plenary Sessions

Background/Purpose: Cortical bone loss is a major determinant of increased fracture risk. Denosumab (DMAb) has been shown to increase BMD at sites of cortical bone, including the radius, a skeletal site not responsive to most osteoporosis treatments. Here, we evaluated changes over time in radius BMD and wrist fracture incidence during 3 years of placebo (Pbo) and up to 5 subsequent years of DMAb therapy in FREEDOM and its Extension (EXT).

Methods: We evaluated 2207 women who received Pbo during FREEDOM (3 years) and enrolled in the EXT to receive DMAb 60 mg Q6M (cross-over group); all women received daily calcium and vitamin D. A subset of these women (n=115) participated in a distal radius DXA substudy and were evaluated at baseline and during FREEDOM and EXT. Analysis of mean percentage changes in BMD over time from FREEDOM and EXT baselines consisted of a repeated measure model. Wrist fracture rates (per 100 subject-years), rate ratios, and 95% CI were computed.

Results: At FREEDOM baseline, the mean (SD) 1/3 radius T-score was –2.53 (1.18). During FREEDOM, daily calcium and vitamin D alone was associated with a progressive and significant loss of BMD at the 1/3 radius (–1.2%); however, during EXT, DMAb halted and reversed bone loss (Figure). With 5 years of DMAb treatment, a significant gain in BMD (1.5% at EXT Year 5) was observed, compared with EXT baseline. The wrist fracture rate during the Pbo period in FREEDOM was 1.02 (0.80–1.29) per 100 subject-years. During the first 3 years of EXT, BMD recovered to the original baseline levels in response to DMAb and the wrist fracture rate remained comparable to the FREEDOM Pbo rate (Table); with 2 additional years of DMAb treatment, BMD increased further and the wrist fracture rate declined to levels significantly lower than the FREEDOM Pbo rate (rate ratio=0.57, 95% CI=0.34–0.95; p=0.03).

Conclusion: In untreated women with postmenopausal osteoporosis, cortical bone density at the radius declined significantly. DMAb treatment for 3 years fully reversed this bone loss, and 2 additional years of treatment resulted in further BMD gains that translated to significantly lower wrist fracture rates, highlighting the clinical importance of reversing cortical bone loss.

 


Disclosure:

J. Bilezikian,

NIH, Amgen Inc., NPS,

2,

Columbia University,

3,

Merck, Amgen Inc., NPS, Lilly, Johnson&Johnson,

5,

Elsevier Press,

7;

C. Benhamou,

Amgen Inc., MSD, Servier,

2,

Amgen Inc., Lilly, Novartis, Roche, Rottapharm, Servier,

5;

C. Lin,

Amgen Inc.,

1,

Amgen Inc.,

3;

J. Brown,

Actavis, Amgen Inc., Eli Lilly, Merck, Novartis,

2,

Amgen Inc., Eli Lilly,

5,

Amgen Inc., Eli Lilly,

8;

N. Daizadeh,

Amgen Inc.,

1,

Amgen Inc.,

3;

P. Ebeling,

Amgen Inc., GSK, Eli-Lilly, Merck, Novartis,

2,

GSK, Amgen Inc., Merck,

5;

A. Fahrleitner-Pammer,

Roche,

2,

Amgen Inc., GSK, Eli Lilly, Servier, Pfizer,

8;

E. Franek,

Amgen Inc., Novartis,

5,

Amgen Inc., Eli Lilly, Novartis, Servier, TEVA,

8;

N. Gilchrist,
None;

P. Miller,

Amgen Inc., Merck, Lilly, Takeda, Radius, Boehringer, Novo Nordisk,

2,

Merck, Amgen Inc., Lilly,

5;

J. Simon,

AbbVie Inc., Actavis, PLC., EndoCeutics Inc., Novo Nordisk, Novogyne, Palatin Technologies, Teva Pharmaceutical Industries Ltd,

2,

AbbVie Inc., Actavis, PLC., Amgen Inc., Apotex Inc., Ascend Therapeutics, Depomed Inc., Everett Laboratories Inc., Lupin Pharmaceuticals, TherapeuticsMD, Meda Pharmaceuticals Inc., Merck and Co Inc., Novartis Pharmaceuticals Corp,,

5,

Amgen Inc., Eisai Inc., Merck, Noven Pharmaceuticals Inc., Shionogi Inc., Teva Pharmaceutical Industries Ltd,

8;

I. Valter,
None;

C. Zerbini,

Pfizer, Lilly, Merck, Amgen Inc., Novartis,

2,

MSD, Lilly, Pfizer, Servier,

5,

Pfizer, Lilly, Servier,

8;

C. Libanati,

Amgen Inc.,

1,

Amgen Inc.,

3.

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to 2014 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/denosumab-restores-cortical-bone-loss-at-the-distal-radius-associated-with-aging-and-reduces-wrist-fracture-risk-analyses-from-the-cross-over-group-in-the-extension-of-the-denosumab-pivotal-fracture/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology