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Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan | Clinical Trials | Clareo Health

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Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan

Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)

NCT01397955•Bayer

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.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patients who received Julina for postmenopausal osteoporosis

Exclusion Criteria

•Patients who are contraindicated based on the product label

Locations (1)

Many Locations, Japan

Key Dates

Start Date

January 1, 2009

Primary Completion Date

January 1, 2014

Completion Date

April 1, 2014

Last Updated

April 17, 2015

Enrollment

148

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

E2 transdermal (Julina, BAY86-5435)

DRUG

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

NCT05575167

Osteoporosis, Postmenopausal

View study

RECRUITINGNA

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

NCT05228262

Osteoporosis, Postmenopausal

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WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

NCT03232476

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects