Effects of Teriparatide Therapy for Japanese

NCT ID: NCT01956461

Last Updated: 2016-10-19

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

2010-09-30

Study Completion Date

2017-10-31

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 daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

Several determinants were reported to be related to subsequent BMD increase, such as baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive discussion is lacking. Specifically, there analyses were performed fragmentarily.

The main objective of this study is to reveal the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.

Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As a result, there is a lot of nursing home. But there are few reports concerning to the efficacy of teriparatide treatment in nursing home patients. The second objective is to reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes, bone turnover makers change, and adverse events.

Detailed Description

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Registry criteria: Patients treated in the investigators hospital using teriparatide. 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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* severe osteoporotic patients

Exclusion Criteria

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

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, PhD

Role: CONTACT

(81)-59-365-0023

Facility Contacts

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Rui Niimi, MD, PhD

Role: primary

(81)-59-365-0023

Other Identifiers

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IRB TH No 6

Identifier Type: -

Identifier Source: org_study_id

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