NCT02977949

Brief Summary

There are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

6.5 years

First QC Date

November 23, 2016

Last Update Submit

November 26, 2016

Conditions

Selective Estrogen Receptor Modulator (SERM)

Keywords

SERMSeasonVariationVitamin D

Outcome Measures

Primary Outcomes (1)

  • Effects of raloxifene on bone mineral density in postmenopausal osteoporosis.

    Up to 36 months

Interventions

RaloxifeneDRUG

Eligibility Criteria

Age45 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Osteoporosis patients using raloxifene more for two years.

You may qualify if:

  • Postmenopausal women

You may not qualify if:

  • Patients who could not use SERM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tomidahama Hospital

Yokkaichi, Mie-ken, 510-8008, Japan

RECRUITING

MeSH Terms

Interventions

Raloxifene Hydrochloride

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Rui Niimi, MD

    Tomidahama Hospital

    STUDY DIRECTOR

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
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Hospital

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 30, 2016

Study Start

January 1, 2012

Primary Completion

July 1, 2018

Study Completion

December 1, 2019

Last Updated

November 30, 2016

Record last verified: 2016-11

Locations

JP(1)