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Trial record 4 of 158 for:    Recruiting, Not yet recruiting, Available Studies | "Osteoporosis"

The Relationship Between the Residual Renal Function and Osteoporosis Treatment

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ClinicalTrials.gov Identifier: NCT02304887
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Osteoporosis Drug: Bis, SERM Teriparatide, Denosumab

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 Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Relationship Between the Residual Renal Function and Osteoporosis Treatment
Study Start Date : January 2006
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. Longitudinal renal function changes by osteoporotic treatment [ Time Frame: Up to 120 months ]

Eligibility Criteria

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Osteoporosis treatment patients
Criteria

Inclusion Criteria:

  • Osteoporosis patients

Exclusion Criteria:

  • eGFR < 15
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304887


Contacts
Contact: Rui Niimi, MD (81)-59-365-0023 furikakefuri@hotmail.co.jp

Locations
Japan
Tomidahama Hospital Recruiting
Yokkaichi, Mie, Japan, 510-8008
Contact: Rui Niimi, MD, PhD    (81)-59-365-0023    furikakefuri@hotmail.co.jp   
Sponsors and Collaborators
Toshihiko Kono
Investigators
Principal Investigator: Rui Niimi, MD Tomidahama Hospital
More Information

Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
ClinicalTrials.gov Identifier: NCT02304887     History of Changes
Other Study ID Numbers: IRB TH No 9-1
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Toshihiko Kono, Tomidahama Hospital:
Osteoporosis
Bone mineral densisty
Renal function
CKD-MBD

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Teriparatide
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Physiological Effects of Drugs
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists