Effects of Denosumab Therapy for Japanese

Last updated: November 23, 2016
Sponsor: Tomidahama Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

N/A

Clinical Study ID

NCT02491515
IRB9-2
  • Ages > 45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Osteoporotic patients

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 500
Study Start date:
July 01, 2012
Estimated Completion Date:
December 31, 2020

Study 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

Connect with a study center

  • Tomidahama Hospital

    Yokkaichi, Mie 510-8008
    Japan

    Active - Recruiting

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