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NCT02304887 Clinical Trial

The Relationship Between the Residual Renal Function and Osteoporosis Treatment

Osteoporosis Clinical Trial

Official title:
The Relationship Between the Residual Renal Function and Osteoporosis Treatment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02304887
Other study ID # IRB TH No 9-1
Secondary ID
Status Recruiting
Phase N/A
First received November 27, 2014
Last updated November 23, 2016
Start date January 2006
Est. completion date January 2019

Study information
Verified date November 2016
Source Tomidahama Hospital
Contact Rui Niimi, MD
Phone (81)-59-365-0023
Email furikakefuri@hotmail.co.jp
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Observational

Clinical Trial Summary

The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date January 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility Inclusion Criteria:

- Osteoporosis patients

Exclusion Criteria:

- eGFR < 15

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Bis, SERM Teriparatide, Denosumab
Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.

Locations
Country Name City State
Japan Tomidahama Hospital Yokkaichi Mie

Sponsors (1)
Lead Sponsor Collaborator
Toshihiko Kono

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Longitudinal renal function changes by osteoporotic treatment Up to 120 months Yes
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