The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.
Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody
Abstract
Sclerostin, an osteocyte-secreted protein, negatively regulates osteoblasts and inhibits bone formation. In this first-in-human study, a sclerostin monoclonal antibody (AMG 785) was administered to healthy men and postmenopausal women. In this phase I, randomized, double-blind, placebo-controlled, ascending, single-dose study, 72 healthy subjects received AMG 785 or placebo (3:1) subcutaneously (0.1, 0.3, 1, 3, 5, or 10 mg/kg) or intravenously (1 or 5 mg/kg). Depending on dose, subjects were followed for up to 85 days. The effects of AMG 785 on safety and tolerability (primary objectives) and pharmacokinetics, bone turnover markers, and bone mineral density (secondary objectives) were evaluated. AMG 785 generally was well tolerated. One treatment-related serious adverse event of nonspecific hepatitis was reported and was resolved. No deaths or study discontinuations occurred. AMG 785 pharmacokinetics were nonlinear with dose. Dose-related increases in the bone-formation markers procollagen type 1 N-propeptide (P1NP), bone-specific alkaline phosphatase (BAP), and osteocalcin were observed, along with a dose-related decrease in the bone-resorption marker serum C-telopeptide (sCTx), resulting in a large anabolic window. In addition, statistically significant increases in bone mineral density of up to 5.3% at the lumbar spine and 2.8% at the total hip compared with placebo were observed on day 85. Six subjects in the higher-dose groups developed anti-AMG 785 antibodies, 2 of which were neutralizing, with no discernible effect on the pharmacokinetics or pharmacodynamics. In summary, single doses of AMG 785 generally were well tolerated, and the data support further clinical investigation of sclerostin inhibition as a potential therapeutic strategy for conditions that could benefit from increased bone formation. © 2011 American Society for Bone and Mineral Research.
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Cites
Neer, R. M., Arnaud, C. D., Zanchetta, J. R., Prince, R., Gaich, G. A., Reginster, J.-Y., Hodsman, A. B., Eriksen, E. F., Ish-Shalom, S., Genant, H. K., et al. (2001) · New England Journal of Medicine · doi:10.1056/nejm200105103441904 · Cited by 4,602
Sclerostin Binds to LRP5/6 and Antagonizes Canonical Wnt Signaling
Li, X., Zhang, Y., Kang, H., Liu, W., Liu, P., Zhang, J., Harris, S. E., & Wu, D. (2005) · Journal of Biological Chemistry · doi:10.1074/jbc.m413274200 · Cited by 1,366
Increased bone density in sclerosteosis is due to the deficiency of a novel secreted protein (SOST)
Balemans, W. (2001) · Human Molecular Genetics · doi:10.1093/hmg/10.5.537 · Cited by 1,147 · cited 1×
“Individuals who are homozygous for null mutations in SOST, the gene that encodes sclerostin, have sclerosteosis.((8,9)) This syndrome is characterized by progressive bone thickening that results in significant increases in bone mass and bone mineral density (BMD) throughout the skeleton.”
BackgroundOsteocyte control of bone formation via sclerostin, a novel BMP antagonist
Winkler, D. G. (2003) · The EMBO Journal · doi:10.1093/emboj/cdg599 · Cited by 1,112
Brunkow, M. E., Gardner, J. C., Van Ness, J., Paeper, B. W., Kovacevich, B. R., Proll, S., Skonier, J. E., Zhao, L., Sabo, P. J., Fu, Y.-H., et al. (2001) · The American Journal of Human Genetics · doi:10.1086/318811 · Cited by 1,011
Monoclonal Antibody Pharmacokinetics and Pharmacodynamics
Wang, W., Wang, E., & Balthasar, J. (2008) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2008.170 · Cited by 978
Sclerostin is a delayed secreted product of osteocytes that inhibits bone formation
Poole, K. E. S., Van Bezooijen, R. L., Loveridge, N., Hamersma, H., Papapoulos, S. E., Löwik, C. W., & Reeve, J. (2005) · The FASEB Journal · doi:10.1096/fj.05-4221fje · Cited by 965
Li, X., Ominsky, M. S., Niu, Q.-T., Sun, N., Daugherty, B., D'Agostin, D., Kurahara, C., Gao, Y., Cao, J., Gong, J., et al. (2008) · Journal of Bone and Mineral Research · doi:10.1359/jbmr.080216 · Cited by 936
van Bezooijen, R. L., Roelen, B. A. J., Visser, A., van der Wee-Pals, L., de Wilt, E., Karperien, M., Hamersma, H., Papapoulos, S. E., ten Dijke, P., & Löwik, C. W. G. M. (2004) · The Journal of Experimental Medicine · doi:10.1084/jem.20031454 · Cited by 892
Li, X., Ominsky, M. S., Warmington, K. S., Morony, S., Gong, J., Cao, J., Gao, Y., Shalhoub, V., Tipton, B., Haldankar, R., et al. (2009) · Journal of Bone and Mineral Research · doi:10.1359/jbmr.081206 · Cited by 784
Cited by
Bonewald, L. F. (2011) · Journal of Bone and Mineral Research · doi:10.1002/jbmr.320 · Cited by 2,287
WNT signaling in bone homeostasis and disease: From human mutations to treatments
Baron, R., & Kneissel, M. (2013) · Nature Medicine · doi:10.1038/nm.3074 · Cited by 2,093
Romosozumab Treatment in Postmenopausal Women with Osteoporosis
Cosman, F., Crittenden, D. B., Adachi, J. D., Binkley, N., Czerwinski, E., Ferrari, S., Hofbauer, L. C., Lau, E., Lewiecki, E. M., Miyauchi, A., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1607948 · Cited by 1,805
Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis
Saag, K. G., Petersen, J., Brandi, M. L., Karaplis, A. C., Lorentzon, M., Thomas, T., Maddox, J., Fan, M., Meisner, P. D., & Grauer, A. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1708322 · Cited by 1,544
Romosozumab in Postmenopausal Women with Low Bone Mineral Density
McClung, M. R., Grauer, A., Boonen, S., Bolognese, M. A., Brown, J. P., Diez-Perez, A., Langdahl, B. L., Reginster, J.-Y., Zanchetta, J. R., Wasserman, S. M., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1305224 · Cited by 1,258
Metadata
- Authors
- Padhi, D., Jang, G., Stouch, B., Fang, L., & Posvar, E.
- Venue
- Journal of Bone and Mineral Research
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-12-22
- Volume
- 26
- Issue
- 1
- Pages
- 19-26
- ISSN
- 0884-0431 (ISSN-L)
- 1523-4681
- OpenAlex
- W2032956576
- Cited by
- 786
- References
- 28
- FWCI
- 70.47
- Type
- journal article
- Language
- en
- Open access
- closed
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- Padhi, D., Jang, G., Stouch, B., Fang, L., & Posvar, E. (2011). Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. Journal of Bone and Mineral Research. https://doi.org/10.1002/jbmr.173
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