NCT01401114

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 Wellnara for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Wellnara in clinical practice. A total 400 patients will be recruited and followed 3 years since starting Wellnara administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

March 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

5.4 years

First QC Date

July 22, 2011

Last Update Submit

September 25, 2015

Conditions

Osteoporosis, Postmenopausal

Keywords

WellnaraPostmenopausal osteoporosis

Outcome Measures

Primary Outcomes (1)

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

    After Wellnara administration, up to 3 years

Secondary Outcomes (2)

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

    At baseline and after Wellnara administration, up to 3 years

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

    At baseline and after Wellnara treatment, up to 3 years

Study Arms (1)

Group 1

Drug (incl. Placebo)

Drug: E2/LNG oral (Wellnara, BAY86-5029)

Interventions

E2/LNG oral (Wellnara, BAY86-5029)DRUG

Patients in daily life treatment receiving Wellnara 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 Wellnara on the basis of the decision of the treating gynecologist. The study is expected to collect data of 400 patients in about 80 gynecological practices in Japan.

You may qualify if:

  • Patients who received Wellnara 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 22, 2011

First Posted

July 25, 2011

Study Start

March 1, 2009

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

JP(1)