Universität zu Köln

Graeff, Christian ORCID: 0000-0002-5296-7649, Campbell, Graeme M., Pena, Jaime, Borggrefe, Jan ORCID: 0000-0003-2908-7560, Padhi, Desmond, Kaufman, Allegra, Chang, Sung, Libanati, Cesar and Glueer, Claus-Christian (2015). Administration of romosozumab improves vertebral trabecular and cortical bone as assessed with quantitative computed tomography and finite element analysis. Bone, 81. S. 364 - 370. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1873-2763

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Abstract

Romosozumab inhibits sclerostin, thereby increasing bone formation and decreasing bone resorption. This dual effect of romosozumab leads to rapid and substantial increases in areal bone mineral density (aBMD) as measured by dual-energy X-ray absorptiometry (DXA). In a phase 1b, randomized, double-blind, placebo-controlled study, romosozumab or placebo was administered to 32 women and 16 men with low aBMD for 3 months, with a further 3-month follow-up: women received six doses of 1 or 2 mg/kg every 2 weeks (Q2W) or three doses of 2 or 3 mg/kg every 4 weeks (Q4W); men received 1 mg/kg Q2W or 3 mg/kg Q4W. Quantitative computed tomography (QCT) scans at lumbar (L1-2) vertebrae and high-resolution QCT (HR-QCT) scans at thoracic vertebra (T12) were analyzed in a subset of subjects at baseline, month 3, and month 6. The QCT subset included 24 romosozumab and 9 placebo subjects and the HR-QCT subset included 11 romosozumab and 3 placebo subjects. The analyses pooled the romosozumab doses. Linear finite element modeling of bone stiffness was performed. Compared with placebo, the romosozumab group showed improvements at month 3 for trabecular BMD by QCT and HR-QCT, HR-QCT trabecular bone volume fraction (BV/TV) and separation,, density-weighted cortical thickness, and QCT stiffness (all p < 0.05). At month 6, improvements from baseline were observed in QCT trabecular BMD and stiffness, and. in HR-QCT BMD, trabecular BV/TV and separation, density-weighted cortical thickness, and stiffness in the romosozumab group (all p < 0.05 compared with placebo). The mean (SE) increase in HR-QCT stiffness with romosozumab from baseline was 26.9% +/- 6.8% and 35.0% +/- 6.8% at months 3 and 6, respectively; subjects administered placebo had changes of -2.7% +/- 13.4% and -6.4% +/- 13.4%, respectively. In conclusion, romosozumab administered for 3 months resulted in rapid and large improvements in trabecular and cortical bone mass and structure as well as whole bone stiffness, which continued 3 months after the last romosozumab,dose. (C) 2015 Published by Elsevier Inc.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Graeff, Christian UNSPECIFIED orcid.org/0000-0002-5296-7649 UNSPECIFIED Campbell, Graeme M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pena, Jaime UNSPECIFIED UNSPECIFIED UNSPECIFIED Borggrefe, Jan UNSPECIFIED orcid.org/0000-0003-2908-7560 UNSPECIFIED Padhi, Desmond UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaufman, Allegra UNSPECIFIED UNSPECIFIED UNSPECIFIED Chang, Sung UNSPECIFIED UNSPECIFIED UNSPECIFIED Libanati, Cesar UNSPECIFIED UNSPECIFIED UNSPECIFIED Glueer, Claus-Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-385539
DOI:	10.1016/j.bone.2015.07.036
Journal or Publication Title:	Bone
Volume:	81
Page Range:	S. 364 - 370
Date:	2015
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1873-2763
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language POSTMENOPAUSAL WOMEN; MEN; MICROSTRUCTURE; STRENGTH; OSTEOPOROSIS; TERIPARATIDE; FRACTURES; DENSITY; MASS; AGE Multiple languages Endocrinology & Metabolism Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/38553