Effects of Denosumab Therapy for Japanese

Effects of Denosumab Therapy for Japanese Osteoporotic Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02491515

Enrollment

500

Registered

2015-07-08

Start date

2012-07-31

Completion date

2020-12-31

Last updated

2016-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Osteoporosis, BMD, denosumab, previous therapy

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

Interventions

DRUGDenosumab

every 6 month injection

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Osteoporotic patients

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
BMD increase by denosumab in Japanese	Up to 48 months	The investigators evaluate BMD increase by denosmab in Japanese patients.

Secondary

Measure	Time frame	Description
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.
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.

Countries

Japan

Contacts

Primary ContactRui Niimi, MD

furikakefuri@hotmail.co.jp+81593650023

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026