Early clinical effects, safety, and appropriate selection of bone markers in romosozumab treatment for osteoporosis patients: a 6-month study

Summary Our 6-month study showed the usefulness of romosozumab for preventing fractures and its safety. It was effective in patients with low baseline spine BMD, high TRACP-5b, and high iP1NP. Percent change from baseline of TRACP-5b and iP1NP after 1 month correlated with that from baseline of BMD...

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Bibliographic Details
Published in:Osteoporosis international 2021-04, Vol.32 (4), p.653-661
Main Authors: Tominaga, A., Wada, K., Kato, Y., Nishi, H., Terayama, Y., Okazaki, K.
Format: Article
Language:English
Subjects:
Acid phosphatase (tartrate-resistant)
Adverse events
Antibodies, Monoclonal - adverse effects
Biomarkers
Bone Density
Bone Density Conservation Agents - adverse effects
Bone growth
Bone mineral density
Bone resorption
Bone turnover
Cardiovascular diseases
Endocrinology
Fractures
Hip
Humans
Japan
Medicine
Medicine & Public Health
Monoclonal antibodies
Original Article
Orthopedics
Osteogenesis
Osteoporosis
Osteoporosis - drug therapy
Patients
Procollagen
Rheumatology
Safety
SOST protein
Spine
Vertebrae
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Summary:Summary Our 6-month study showed the usefulness of romosozumab for preventing fractures and its safety. It was effective in patients with low baseline spine BMD, high TRACP-5b, and high iP1NP. Percent change from baseline of TRACP-5b and iP1NP after 1 month correlated with that from baseline of BMD after four to 6-month treatment. Introduction Romosozumab appeared as a new osteoporosis medication in Japan in 2019. It is an anti-sclerostin antibody which increases bone formation and suppresses bone resorption. In this study, we analyzed the actual clinical effects, adverse effects, and the optimal way to evaluate the treatment. Methods Romosozumab was administered as subcutaneous injection of 210 mg once every 4 weeks. We conducted pre-post study in 185 patients treated for 6 months. We focused on the incidence of new vertebral fractures, safety, bone mineral density (BMD) at the spine and total hip, and bone metabolism markers. We evaluated BMD before romosozumab treatment and after 4 to 6 months and performed the serum analysis before romosozumab treatment, after 1, 3, and 6 months. Results There was no new fracture during treatment, and there was no fatal adverse event including cardiovascular disease. Since percent changes from baseline of the spine and total hip BMD were 6.34% and 1.53% after 4- to 6-month treatment, the treatment was effective for spine osteoporosis. Tartrate-resistant acid phosphatase 5b (TRACP-5b) and intact type I procollagen N-terminal propeptide (iP1NP) had significant changes during romosozumab treatment ( p  
ISSN:0937-941X
1433-2965
DOI:10.1007/s00198-020-05639-y