NCT02166437

Brief Summary

In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

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 Nov 2013

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

November 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

June 15, 2014

Last Update Submit

October 18, 2016

Conditions

Osteoporosis

Keywords

osteoporosisBMDteriparatidebisphosphonatedenosmab

Outcome Measures

Primary Outcomes (1)

  • Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment

    The investigators plan to analyze 500 patients who treated with bisphosphonate or denosmab following daily teriparatide treatment. We investigate changes in BMD and bone turnover markers.

    Up to 36 months

Study Arms (3)

Alendronate

Patients treated with alendronate

Minodronate

Patients treated with minodronate

Denosmab

Patients treated with denosmab

Eligibility Criteria

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

tion Osteoporotic patients who admit to our hospital

You may qualify if:

  • severe osteoporotic patients

You may not qualify if:

  • cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, teriparatide)

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

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rui Niimi, MD, PhD

    Tomidahama Hospital

    STUDY DIRECTOR

Central Study Contacts

Rui Niimi, MD, PhD

CONTACT

(81)-59-365-0023furikakefuri@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 15, 2014

First Posted

June 18, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2017

Study Completion

November 1, 2018

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

JP(1)