NCT01973738

Brief Summary

Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.

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
300

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

5.9 years

First QC Date

October 25, 2013

Last Update Submit

October 18, 2016

Conditions

Selective Estrogen Receptor Modulator

Keywords

raloxifenebazedoxifenebone mineral densitybone turnover markersbone quality

Outcome Measures

Primary Outcomes (1)

  • Effects of raloxifene vs. bazedoxifene on bone mineral density, bone turnover markers and bone quality markers in postmenopausal osteoporosis.

    The investigators plan to analyze 300 patients who undergo selective estrogen receptor modulator (SERM) treatments for five years. We investigate the efficacy of two SERMs: raloxifene (RLX) and bazedoxifene (BZA). Bone mineral density (BMD) andd laboratory analyses (bone markers, routine chemistry, urine, and bone quality marker of pentosidine) at baseline and every four to six months. We also investigate the side effects. Statical analyses are performed using Spearman correlation coefficients, paired t-test, Mann-Whitney U test, chi-square test and Fisher's exact test to compare the efficacy and safy between RLX and BZA.

    Up to 72 months

Eligibility Criteria

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

Osteoporosis patients using SERM more for five 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

Study Design

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

Study Record Dates

First Submitted

October 25, 2013

First Posted

October 31, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

JP(1)