Effects of Denosumab Therapy for Japanese

• Conditions: Osteoporosis

• Registration Number: NCT02491515
• Lead Sponsor: Tomidahama Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-06-27
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25
• Primary Completion: 2017-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Osteoporotic patients

Exclusion Criteria

• cancer, hypercalcemia, etc (i.e. patients who could not use denosumab)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMD increase by denosumab in Japanese	Up to 48 months	The investigators evaluate BMD increase by denosmab in Japanese patients.

Secondary Outcome Measures

Name	Time	Method
Effects of previous therapy to denosumab	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.
The determinants related to BMD increase and fracture prevention for denosumab treatment	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.

Trial Locations

Locations (1)

Tomidahama Hospital; 🇯🇵 Yokkaichi, Mie, Japan