NCT01397955

Brief Summary

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

5 years

First QC Date

July 19, 2011

Last Update Submit

April 16, 2015

Conditions

Osteoporosis, Postmenopausal

Keywords

JulinaPostmenopausal osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse drug reactions and serious adverse events in subject who received Julina

    After Julina administration, upto 3 years

Secondary Outcomes (2)

  • Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease, hysterectomy) and dose of Julina

    At baseline and after Julina administration, upto 3 years

  • Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse

    At baseline and at end of Julina treatment, upto 3 years

Study Arms (1)

Group 1

Drug (incl. Placebo)

Drug: E2 transdermal (Julina, BAY86-5435)

Interventions

E2 transdermal (Julina, BAY86-5435)DRUG

Patients in daily life treatment receiving Julina for postmenopausal osteoporosis

Group 1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population of this study is patients who have received a prescription of Julina on the basis of the decision of the treating gynecologist. The study is expected to collect data of 100 patients in about 20 gynecological practices in Japan.

You may qualify if:

  • Patients who received Julina for postmenopausal osteoporosis

You may not qualify if:

  • Patients who are contraindicated based on the product label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 20, 2011

Study Start

January 1, 2009

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

JP(1)