NCT02491515

Effects of Denosumab Therapy for Japanese

Effects of Denosumab Therapy for Japanese Osteoporotic Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Tomidahama Hospital · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Denosumab	every 6 month injection

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-06-01
• Completion: 2020-12-01
• First posted: 2015-07-08
• Last updated: 2016-11-25

Locations

1 site across 1 country: Japan