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

October 18, 2016 updated by: Toshihiko Kono, Tomidahama Hospital

Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese, Prospective Study

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Mie
      • Yokkaichi, Mie, Japan, 510-8008
        • Recruiting
        • Tomidahama Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

tion Osteoporotic patients who admit to our hospital

Description

Inclusion Criteria:

  • severe osteoporotic patients

Exclusion Criteria:

  • cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, teriparatide)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Alendronate
Patients treated with alendronate
Minodronate
Patients treated with minodronate
Denosmab
Patients treated with denosmab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment
Time Frame: Up to 36 months

The investigators plan to analyze 500 patients who treated with bisphosphonate or denosmab following daily teriparatide treatment.

We investigate changes in BMD and bone turnover markers.
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomidahama Hospital

Investigators

  • Study Director: Rui Niimi, MD, PhD, Tomidahama Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

June 15, 2014

First Submitted That Met QC Criteria

June 15, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB TH No 6-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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