The Relationship Between the Residual Renal Function and... | NCT02304887

Studies
The Relationship Between the Residual Renal Function and Osteoporosis Treatment

NCT02304887

Sponsor

Toshihiko Kono

Status

Unknown status

Last Update Posted

Nov 25, 2016Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Osteoporosis

Interventions

Bis, SERM Teriparatide, Denosumab

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Nov 27, 2014

First Submission Date that Met QC Criteria

Nov 27, 2014

First Posted Date

Dec 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2016

Last Update Posted Date

Nov 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bisphosphonate			Drug: Bis, SERM Teriparatide, Denosumab
Selective estrogen receptor modulator			Drug: Bis, SERM Teriparatide, Denosumab
Teriparatide			Drug: Bis, SERM Teriparatide, Denosumab
Senosumab			Drug: Bis, SERM Teriparatide, Denosumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bis, SERM Teriparatide, Denosumab	Drug	Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.	Bisphosphonate Selective estrogen receptor modulator

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Osteoporosis patients

Exclusion Criteria:

eGFR < 15

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Osteoporosis treatment patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rui Niimi, MD	Contact	(81)-59-365-0023		furikakefuri@hotmail.co.jp

Overall Officials

Name	Affiliation	Role
Rui Niimi, MD	Tomidahama Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tomidahama Hospital	Recruiting	Yokkaichi	Mie-ken	510-8008	Japan

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D012080	Chronic Kidney Disease-Mineral and Bone Disorder

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069448	Denosumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided