Effects of Denosumab Therapy for Japanese

Osteoporosis Clinical Trial

Official title:

Effects of Denosumab Therapy for Japanese Osteoporotic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02491515
• Other study ID #: IRB9-2
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2015
• Last updated: November 23, 2016
• Start date: July 2012
• Est. completion date: December 2020

Study information

• Verified date: November 2016
• Source: Tomidahama Hospital
• Contact: Rui Niimi, MD
• Phone: +81593650023
• Email: furikakefuri[@]hotmail.co.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2020
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Osteoporotic patients

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Denosumab
every 6 month injection

Locations

Country	Name	City	State
Japan	Tomidahama Hospital	Yokkaichi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Tomidahama Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD increase by denosumab in Japanese	The investigators evaluate BMD increase by denosmab in Japanese patients.	Up to 48 months	Yes
Secondary	The determinants related to BMD increase and fracture prevention for denosumab treatment	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.	Up to 48 months	Yes
Secondary	Effects of previous therapy to denosumab	The investigators evaluate effects of previous osteoporosis treatment to denosumab in BMD increase and bone turnover marker response using univariate and multivariate analysis.	Up to 48 months	Yes