NCT02491515

Brief Summary

In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of denosumab in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition. The main objective of this study is to investigate effects of denosumab. The researchers also investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment. In this study, the investigators analyse the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

4.9 years

First QC Date

June 27, 2015

Last Update Submit

November 23, 2016

Conditions

Osteoporosis

Keywords

OsteoporosisBMDdenosumabprevious therapy

Outcome Measures

Primary Outcomes (1)

  • BMD increase by denosumab in Japanese

    The investigators evaluate BMD increase by denosmab in Japanese patients.

    Up to 48 months

Secondary Outcomes (2)

  • The determinants related to BMD increase and fracture prevention for denosumab treatment

    Up to 48 months

  • Effects of previous therapy to denosumab

    Up to 48 months

Interventions

DenosumabDRUG

every 6 month injection

Also known as: Prolia

Eligibility Criteria

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

Osteoporotic patients who admit to our hospital

You may qualify if:

  • Osteoporotic patients

You may not qualify if:

  • cancer, hypercalcemia, etc (i.e. patients who could not use denosumab)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tomidahama Hospital

Yokkaichi, Mie-ken, 510-8008, Japan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Rui Niimi, MD

    Tomidahama Hospital

    STUDY DIRECTOR

Central Study Contacts

Rui Niimi, MD

CONTACT

+81593650023furikakefuri@hotmail.co.jp

Study Design

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

Study Record Dates

First Submitted

June 27, 2015

First Posted

July 8, 2015

Study Start

July 1, 2012

Primary Completion

June 1, 2017

Study Completion

December 1, 2020

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

JP(1)