NCT02304887

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

12.9 years

First QC Date

November 27, 2014

Last Update Submit

November 23, 2016

Conditions

Osteoporosis

Keywords

OsteoporosisBone mineral densistyRenal functionCKD-MBD

Outcome Measures

Primary Outcomes (1)

  • Longitudinal renal function changes by osteoporotic treatment

    Up to 120 months

Study Arms (4)

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

Bis, SERM Teriparatide, DenosumabDRUG

Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.

BisphosphonateSelective estrogen receptor modulatorSenosumabTeriparatide

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Osteoporosis treatment patients

You may qualify if:

  • Osteoporosis patients

You may not qualify if:

  • eGFR \< 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tomidahama Hospital

Yokkaichi, Mie-ken, 510-8008, Japan

RECRUITING

MeSH Terms

Conditions

OsteoporosisChronic Kidney Disease-Mineral and Bone Disorder

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesRicketsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidism, SecondaryHyperparathyroidismParathyroid DiseasesEndocrine System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Rui Niimi, MD

    Tomidahama Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Niimi, MD

CONTACT

(81)-59-365-0023furikakefuri@hotmail.co.jp

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Hospital

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 2, 2014

Study Start

January 1, 2006

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

JP(1)