The Relationship Between the Residual Renal Function and Osteoporosis Treatment

November 23, 2016 updated by: Toshihiko Kono
The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic kidney disease (CKD)- mineral and bone disorder (CKD-MBD) is one of the topic in osteoporosis treatment. As many osteoporotic patients are older, many patients are under the deterioration of the renal function. In addition, several drugs might have the potential for kidney damage. But the relationship between osteoporosis drugs and kidney damage is unclear.

The main objective of this study is to reveal relationship between osteoporosis drugs and kidney damage.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

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

Study Contact

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

Osteoporosis treatment patients

Description

Inclusion Criteria:

  • Osteoporosis patients

Exclusion Criteria:

  • eGFR < 15

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
Intervention / Treatment
Bisphosphonate
Drug: Bis, SERM Teriparatide, Denosumab
Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.
Selective estrogen receptor modulator
Drug: Bis, SERM Teriparatide, Denosumab
Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.
Teriparatide
Drug: Bis, SERM Teriparatide, Denosumab
Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.
Senosumab
Drug: Bis, SERM Teriparatide, Denosumab
Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Longitudinal renal function changes by osteoporotic treatment
Time Frame: Up to 120 months
Up to 120 months

Collaborators and Investigators

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

Sponsor

Toshihiko Kono

Investigators

  • Principal Investigator: Rui Niimi, MD, 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

January 1, 2006

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

November 27, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB TH No 9-1

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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