check_circleStudy Completed

Osteoporosis, postmenopausal

Bayer Identifier:

15075

ClinicalTrials.gov Identifier:

NCT01397955

EudraCT Number:

Not Available

EU CT Number:

Not Available
Julina post-marketing surveillance for postmenopausal osteoporosis in Japan

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

0 - N/A
  • - Patients who received Julina for postmenopausal osteoporosis
  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
148
Trial Dates
January 2009 - April 2014
Phase
N/A
Could I Receive a placebo
No
Products
Julina (Estradiol, BAY86-5435)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions and serious adverse events in subject who received Julina
    date_rangeTime Frame:
    After Julina administration, upto 3 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease, hysterectomy) and dose of Julina
    date_rangeTime Frame:
    At baseline and after Julina administration, upto 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse
    date_rangeTime Frame:
    At baseline and at end of Julina treatment, upto 3 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

Drug use investigation of Julina Tablets 0.5 mg (postmenopausal osteoporosis)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for websynopsis results posting provided by Bayer.