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Effects of Denosumab Therapy for Japanese

NCT ID: NCT02491515

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Osteoporosis

Keywords

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Osteoporosis BMD denosumab previous therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Denosumab

every 6 month injection

Intervention Type DRUG

Other Intervention Names

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Prolia

Eligibility Criteria

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Inclusion Criteria

* Osteoporotic patients

Exclusion Criteria

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

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tomidahama Hospital

OTHER

Sponsor Role lead

Responsible Party

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Toshihiko Kono

Head of Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rui Niimi, MD

Role: STUDY_DIRECTOR

Tomidahama Hospital

Locations

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Tomidahama Hospital

Yokkaichi, Mie-ken, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Rui Niimi, MD

Role: CONTACT

Phone: +81593650023

Email: [email protected]

Facility Contacts

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Rui Niimi, MD, PhD

Role: primary

Other Identifiers

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IRB9-2

Identifier Type: -

Identifier Source: org_study_id