Impact of denosumab on the peripheral skeleton of postmenopausal women with osteoporosis: bone density, mass, and strength of the radius, and wrist fracture

Simon, James A., Recknor, Christopher, Moffett, Alfred H., Jr., Adachi, Jonathan D., Franek, Edward, Lewiecki, E. Michael, McClung, Michael R., Mautalen, Carlos A., Ragi-Eis, Sergio, Nicholson, Geoffrey C., Muschitz, Christian, Nuti, Ranuccio, Torring, Ove, Wang, Andrea and Libanati, Cesar (2013) Impact of denosumab on the peripheral skeleton of postmenopausal women with osteoporosis: bone density, mass, and strength of the radius, and wrist fracture. Menopause-The Journal of the North American Menopause Society, 20 2: 130-137. doi:10.1097/gme.0b013e318267f909

Attached Files (Some files may be inaccessible until you login with your UQ eSpace credentials)
Name Description MIMEType Size Downloads

Author Simon, James A.
Recknor, Christopher
Moffett, Alfred H., Jr.
Adachi, Jonathan D.
Franek, Edward
Lewiecki, E. Michael
McClung, Michael R.
Mautalen, Carlos A.
Ragi-Eis, Sergio
Nicholson, Geoffrey C.
Muschitz, Christian
Nuti, Ranuccio
Torring, Ove
Wang, Andrea
Libanati, Cesar
Title Impact of denosumab on the peripheral skeleton of postmenopausal women with osteoporosis: bone density, mass, and strength of the radius, and wrist fracture
Journal name Menopause-The Journal of the North American Menopause Society   Check publisher's open access policy
ISSN 1072-3714
1530-0374
Publication date 2013-02
Year available 2013
Sub-type Article (original research)
DOI 10.1097/gme.0b013e318267f909
Volume 20
Issue 2
Start page 130
End page 137
Total pages 8
Place of publication Philadelphia, PA, United States
Publisher Lippincott Williams & Wilkins
Collection year 2014
Language eng
Formatted abstract
Objective: The aim of this study was to report the effects of denosumab on radius cortical and trabecular bone density, mass, and strength, and wrist fracture incidence in the FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) study.
Methods: In the FREEDOM study, postmenopausal women with osteoporosis (N = 7,808) received placebo or 60 mg of denosumab every 6 months for 36 months. Radius bone mineral density (BMD), bone mineral content, and strength (polar moment of inertia) were evaluated in two prespecified substudies using dual-energy x-ray absorptiometry (placebo, n = 209; denosumab, n = 232) or quantitative CT (placebo, n = 48; denosumab, n = 62). Prespecified analysis assessed wrist fracture incidence in all FREEDOM participants (placebo, N = 3,906; denosumab, N = 3,902), and post hoc subgroup analyses evaluated those with higher fracture risk (baseline femoral neck T-score ≤ –2.5; placebo, N = 1,406; denosumab, N = 1,384).
Results: Denosumab significantly increased areal BMD (assessed by dual-energy x-ray absorptiometry) and volumetric BMD, bone mineral content, and polar moment of inertia (assessed by quantitative CT), compared with placebo, in radius cortical and trabecular bone at all time points evaluated (all P < 0.05). Wrist fracture incidence was 2.9% for placebo and 2.5% for denosumab (relative risk reduction, 16%; P = 0.21) on month 36. Participants with a femoral neck T-score of –2.5 or lower were at increased risk for wrist fracture, and denosumab significantly reduced wrist fracture incidence compared with placebo (placebo, 4.0%; denosumab, 2.4%; relative risk reduction, 40%; absolute risk reduction, 1.6%; P = 0.03).
Conclusions: Denosumab significantly improves radius bone density, mass, and strength compared with placebo. In higher-risk women, denosumab significantly reduces wrist fracture risk.
Keyword Bone mineral density
Strength
Denosumab
Radius
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 2 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 13 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Sun, 03 Mar 2013, 01:01:35 EST by System User on behalf of Rural Clinical School