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Abstract Number: 3175

Strength at the Lumbar Spine and Hip Improves with Romosozumab Compared with Teriparatide in Postmenopausal Women with Low Bone Mass

TM Keaveny1, DB Crittenden2, MA Bolognese3, HK Genant4, K Engelke5, B Oliveri6, JP Brown7, BL Langdahl8, YC Yang2, A Grauer2 and C Libanati9, 1UC Berkeley, Berkeley and O.N. Diagnostics, Berkeley, CA, 2Amgen Inc., Thousand Oaks, CA, 3The Bethesda Health Research Center, Bethesda, MD, 4UCSF & Synarc Inc., San Francisco, CA, 5Synarc Germany, Hamburg, Germany, 6Hospital de Clínicas, INIGEM, Buenos Aires, Argentina, 7Laval University and CHU de Québec (CHUL) Research Centre, Québec City, QC, Canada, 8Aarhus University Hospital, Aarhus, Denmark, 9UCB Pharma, Brussels, Belgium

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Osteoporosis and strength

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Session Information

Date: Tuesday, November 10, 2015

Session Title: Osteoporosis and Metabolic Bone Disease - Clinical Aspects and Pathogenesis

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Romosozumab is a
bone-forming agent that inhibits sclerostin. In a phase 2 study (NCT00896532), 12
months of romosozumab increased DXA bone mineral density (BMD) in
postmenopausal women with low bone mass (McClung et al. NEJM 2014). A
subset of these women underwent spine and hip quantitative computed tomography
(QCT) imaging, confirming the BMD gains (romosozumab vs teriparatide integral volumetric
BMD gains of 17.7% vs 12.9% at the spine and 4.1% vs 1.2% at the hip). To investigate
the effects of romosozumab on bone strength, we performed a finite element
analysis (FEA) on these QCT scans.

Methods: This international
randomized study enrolled postmenopausal women with lumbar spine, total hip, or
femoral neck T‑scores ≤–2.0 and ≥–3.5. In this analysis, subjects
received blinded subcutaneous romosozumab 210 mg monthly, placebo, or open-label
teriparatide (20 mcg daily). QCT scans were performed at the L1 and L2 lumbar vertebrae
and proximal femur at baseline and month 12. Subject-specific vertebral strength
for a simulated compression overload and femoral strength for a simulated
sideways fall were estimated blinded-to-treatment using a FDA-approved
non-linear 3D FEA (VirtuOst,
O.N. Diagnostics). Whole-bone and compartment strength changes were estimated. The
“cortical” compartment was defined as all bone within 2 mm and 3 mm of the
periosteal surface for the spine and hip, respectively, plus any high-density
bone (>1.0 g/cm3 of apparent density); the trabecular compartment
was defined as all other bone.

Results: At the spine,
romosozumab increased
strength from baseline by 27.3% at month 12, which was substantially higher than
placebo (–3.9%) and teriparatide (18.5%; Figure A). This
strengthening
effect was due to contributions from both the “cortical” and trabecular
compartments. At the hip, despite a small sample size for the romosozumab group,
strength increased compared with baseline for romosozumab (3.6%), but did not change
for placebo or teriparatide (Figure B). Again, both “cortical” and trabecular
compartment changes contributed to the overall strengthening observed with
romosozumab.

Conclusion: Romosozumab increased
strength at the spine and hip over 12 months, with strength improving in the “cortical” and
trabecular compartments at both sites. These strength improvements, documented using
a validated method for assessing fracture risk and monitoring treatment,
confirm and extend existing data and support romosozumab evaluation in the
ongoing phase 3 clinical program.


Disclosure: T. Keaveny, O.N. Diagnostics, 4,Amgen, Agnovos Healthcare, 5; D. Crittenden, Amgen, 3,Amgen, 1; M. Bolognese, Amgen, 5,Amgen, Lilly, 8; H. Genant, Amgen, Lilly, Merck, Novartis, Pfizer, Janssen, Daiichi, Medtronic, Agnovos, Biomarin, Clementia, BioClinica, 5; K. Engelke, Synarc-Bioclinica, 3,Amgen, 5,German and EU research grants, 2; B. Oliveri, Shire HGT, GSK, Servier, 8; J. Brown, Abbvie, Amgen, Eli Lilly, Novartis, Takeda, 2,Amgen, Eli Lilly, Radius, 5,Amgen, Eli Lilly, 8; B. Langdahl, Eli Lilly, Novo Nordisk, Orkla, 2,Amgen, Merck, Eli Lilly, UCB, 5,Amgen, Merck, Eli Lilly, 8; Y. Yang, Amgen, 3,Amgen, 1; A. Grauer, Amgen, 3,Amgen, 1; C. Libanati, Ex employee - Amgen, 3,Amgen, 1,UCB Pharma, 3.

To cite this abstract in AMA style:

Keaveny T, Crittenden D, Bolognese M, Genant H, Engelke K, Oliveri B, Brown J, Langdahl B, Yang Y, Grauer A, Libanati C. Strength at the Lumbar Spine and Hip Improves with Romosozumab Compared with Teriparatide in Postmenopausal Women with Low Bone Mass [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/strength-at-the-lumbar-spine-and-hip-improves-with-romosozumab-compared-with-teriparatide-in-postmenopausal-women-with-low-bone-mass/. Accessed July 1, 2022.
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