Effect of denosumab on trabecular bone score in postmenopausal women with osteoporosis
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Trabecular bone score (TBS) assesses bone quality in the lumbar spine using dual-energy X-ray absorptiometry (DXA) scans. In postmenopausal women with osteoporosis, denosumab significantly improved TBS independently of bone mineral density (BMD). This practical technique may have a role in managing patients with osteoporosis.
TBS, a gray-level texture index determined from lumbar spine DXA scans, correlates with bone microarchitecture and enhances assessment of vertebral fracture risk independently of BMD. In the FREEDOM study, denosumab increased BMD and reduced new vertebral fractures in postmenopausal women with osteoporosis. This retrospective analysis explored the effect of denosumab on TBS and the association between TBS and BMD in FREEDOM.
Postmenopausal women with lumbar spine or total hip BMD T-score <−2.5 and −4.0 or higher at both sites received placebo or denosumab 60 mg subcutaneously every 6 months. TBS indices were determined from DXA scans at baseline and months 12, 24, and 36 in a subset of 285 women (128 placebo, 157 denosumab) who had TBS values at baseline and ≥1 postbaseline visit.
Baseline characteristics were comparable between treatment groups; mean (SD) lumbar spine BMD T-score was −2.79 (0.64), and mean (standard deviation [SD]) TBS was 1.200 (0.101) overall. In the placebo group, BMD and TBS increased by ≤0.2% or decreased from baseline at each visit. In the denosumab group, progressive increases from baseline at 12, 24, and 36 months were observed for BMD (5.7, 7.8, and 9.8%) and TBS (1.4, 1.9, and 2.4%). Percentage changes in TBS were statistically significant compared with baseline (p < 0.001) and placebo (p ≤ 0.014). TBS was largely unrelated to BMD, regardless of treatment, either at baseline or for annual changes from baseline (all r 2 ≤ 0.06).
In postmenopausal women with osteoporosis, denosumab significantly improved TBS independently of BMD.
KeywordsDenosumab Postmenopausal women Trabecular bone score
This work was supported by Amgen Inc. Jonathan Latham (PharmaScribe, LLC, on behalf of Amgen Inc.) and Mandy Suggitt (Amgen Inc.) provided medical writing support.
Compliance with ethical standards
The study complied with the principles of the Declaration of Helsinki. Institutional review boards and ethics committees approved the protocol and consent process. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Subjects provided informed consent to participate.
Conflicts of interest
MR McClung: consultancy—Amgen Inc., Merck, and Radius; and lecture fees—Amgen Inc. and Merck.
K Lippuner: consultancy and principal investigator—Amgen Inc. and MSD.
ML Brandi: research grants—Amgen Inc.
JR Zanchetta: lecture fees—Amgen Inc. and GlaxoSmithKline.
HG Bone: research grants—Amgen Inc. and Merck; consulting fees/honoraria—Amgen Inc., Merck, Radius, and Mission; lecture fees—Amgen Inc.; travel support—Amgen Inc.; fees for review activities—Amgen Inc.; and development of educational presentations—Vindico.
R Chapurlat: research grants, travel support, consultancy, and lecture fees—Amgen Inc.
D Hans: received fees per scan from Amgen to make central calculation of TBS on publication; board membership, stock/stock options, and employment—Medimaps Group; and co-owner of the TBS patent.
A Wang: employee and stock/stock options—Amgen Inc.
C Zapalowski: employee—Radius Health; prior employment—Amgen Inc.; and stock/stock options—Amgen Inc. and Radius Health.
C Libanati: employee—UCB Pharma; and stock/stock options—UCB Pharma and Amgen Inc.
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