Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese

NCT ID: NCT02166437

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

2013-11-30

Study Completion Date

2018-11-30

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 bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

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

Study Groups

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Alendronate

Patients treated with alendronate

No interventions assigned to this group

Minodronate

Patients treated with minodronate

No interventions assigned to this group

Denosmab

Patients treated with denosmab

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* severe osteoporotic patients

Exclusion Criteria

* cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, 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

Principal Investigators

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Rui Niimi, MD, PhD

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, 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 6-3

Identifier Type: -

Identifier Source: org_study_id

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