Effects of Denosumab Therapy for Japanese
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|ClinicalTrials.gov Identifier: NCT02491515|
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : November 25, 2016
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of denosumab in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.
The main objective of this study is to investigate effects of denosumab. The researchers also investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment. In this study, the investigators analyse the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.
|Condition or disease||Intervention/treatment|
Registry criteria: Patients treated in the investigators hospital using denosumab. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (< young adult mean 65%).
Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Effects of Denosumab Therapy for Japanese Osteoporotic Patients|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2020|
- Drug: Denosumab
every 6 month injectionOther Name: Prolia
- BMD increase by denosumab in Japanese [ Time Frame: Up to 48 months ]The investigators evaluate BMD increase by denosmab in Japanese patients.
- The determinants related to BMD increase and fracture prevention for denosumab treatment [ Time Frame: Up to 48 months ]The investigators evaluated lumbar and femoral neck BMD. The investigators evaluated baseline patients characteristics. The investigators will evaluate the relationship between BMD increase or fracture and patients characteristics using univariate and multivariate analysis.
- Effects of previous therapy to denosumab [ Time Frame: Up to 48 months ]The investigators evaluate effects of previous osteoporosis treatment to denosumab in BMD increase and bone turnover marker response using univariate and multivariate analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491515
|Contact: Rui Niimi, MDfirstname.lastname@example.org|
|Yokkaichi, Mie, Japan, 510-8008|
|Contact: Rui Niimi, MD, PhD (81)-59-365-0023 email@example.com|
|Principal Investigator: Rui Niimi, MD, PhD|
|Study Director:||Rui Niimi, MD||Tomidahama Hospital|