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The Effect of Discontinuing Treatment With Blosozumab: Follow-up Results of a Phase 2 Randomized Clinical Trial in Postmenopausal Women With Low Bone Mineral Density.
- Source :
-
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research [J Bone Miner Res] 2015 Sep; Vol. 30 (9), pp. 1717-25. Date of Electronic Publication: 2015 Jun 11. - Publication Year :
- 2015
-
Abstract
- Administration of blosozumab, a humanized monoclonal antibody that binds sclerostin, increases bone formation and bone mineral density (BMD) in postmenopausal women with low BMD. To evaluate the effect of discontinuing blosozumab, we studied women enrolled in a 1-year randomized, placebo-controlled phase 2 trial for an additional year after they completed treatment. Of the 120 women initially enrolled in the study, 106 women completed treatment and continued into follow-up; 88 women completed 1 year of follow-up. At the beginning of follow-up, groups remained balanced for age, race, and body mass index, but lumbar spine and total hip BMD were increased in prior blosozumab groups, reflecting an anabolic treatment effect. At the end of follow-up, 1 year after discontinuing treatment, lumbar spine BMD remained significantly greater than placebo in women initially treated with blosozumab 270 mg every 2 weeks (Q2W) and blosozumab 180 mg Q2W (6.9% and 3.6% above baseline, respectively). Total hip BMD also declined after discontinuation of treatment but at 1 year after treatment remained significantly greater than placebo in women initially treated with blosozumab 270 mg Q2W and blosozumab 180 mg Q2W (3.9% and 2.6% above baseline, respectively). During follow-up, median serum P1NP was not consistently different between the prior blosozumab groups and placebo. A similar pattern was apparent for median serum C-terminal telopeptide of type 1 collagen (CTx) levels, with more variability. Mean serum total sclerostin concentration increased with blosozumab, indicating target engagement, and declined to baseline after discontinuation. There were no adverse events considered related to prior treatment with blosozumab. Anti-drug antibodies generally declined in patients who had detectable levels during prior treatment. These findings support the continued study of blosozumab as an anabolic therapy for treatment of osteoporosis.<br /> (© 2015 American Society for Bone and Mineral Research.)
- Subjects :
- Adaptor Proteins, Signal Transducing
Aged
Antibodies, Monoclonal chemistry
Antibodies, Monoclonal, Humanized blood
Bone Density Conservation Agents administration & dosage
Bone Density Conservation Agents blood
Bone Morphogenetic Proteins immunology
Bone Resorption
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Genetic Markers immunology
Humans
Middle Aged
Osteogenesis
Steroids chemistry
Time Factors
Antibodies, Monoclonal, Humanized administration & dosage
Bone Density
Bone Morphogenetic Proteins blood
Osteoporosis, Postmenopausal drug therapy
Postmenopause
Subjects
Details
- Language :
- English
- ISSN :
- 1523-4681
- Volume :
- 30
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research
- Publication Type :
- Academic Journal
- Accession number :
- 25707611
- Full Text :
- https://doi.org/10.1002/jbmr.2489