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Multiple doses of sclerostin antibody romosozumab in healthy men and postmenopausal women with low bone mass: a randomized, double-blind, placebo-controlled study.
- Source :
-
Journal of clinical pharmacology [J Clin Pharmacol] 2014 Feb; Vol. 54 (2), pp. 168-78. Date of Electronic Publication: 2013 Dec 11. - Publication Year :
- 2014
-
Abstract
- Romosozumab (formerly AMG 785/CDP7851) is a monoclonal antibody that blocks sclerostin from inhibiting osteoblast maturation and function. This double-blind, placebo-controlled, randomized, ascending multiple-dose study enrolled 32 postmenopausal women and 16 healthy men with low bone mass. Women received six doses of 1 or 2 mg/kg once every 2 weeks (Q2W) or three doses of 2 or 3 mg/kg once every 4 weeks (Q4W) or placebo; and men received 1 mg/kg Q2W or 3 mg/kg Q4W or placebo. Mean serum romosozumab exposures increased approximately dose-proportionally. Romosozumab increased serum type 1 aminoterminal propeptide (PINP) by 66-147%, decreased serum C-telopeptide (sCTX) by 15-50%, and increased lumbar spine bone mineral density by 4-7%. Two subjects developed neutralizing antibodies without discernable effects on pharmacokinetics, pharmacodynamics, or safety. Adverse event rates were balanced between groups without any significant safety findings. These data support continued investigation of sclerostin inhibition in disorders that could benefit from increased bone formation.<br /> (© 2013, The American College of Clinical Pharmacology.)
- Subjects :
- Aged
Aged, 80 and over
Bone Density drug effects
Collagen Type I blood
Double-Blind Method
Drug Administration Schedule
Female
Humans
Lumbar Vertebrae drug effects
Male
Middle Aged
Osteoporosis, Postmenopausal blood
Osteoporosis, Postmenopausal metabolism
Peptide Fragments blood
Peptides blood
Procollagen blood
Antibodies, Monoclonal administration & dosage
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal pharmacokinetics
Antibodies, Monoclonal pharmacology
Antibodies, Monoclonal, Humanized administration & dosage
Antibodies, Monoclonal, Humanized adverse effects
Antibodies, Monoclonal, Humanized pharmacokinetics
Antibodies, Monoclonal, Humanized pharmacology
Bone Density Conservation Agents administration & dosage
Bone Density Conservation Agents adverse effects
Bone Density Conservation Agents pharmacokinetics
Bone Density Conservation Agents pharmacology
Osteoporosis, Postmenopausal drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1552-4604
- Volume :
- 54
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Journal of clinical pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 24272917
- Full Text :
- https://doi.org/10.1002/jcph.239