Osteoporosis Treatment in Post-menopausal Women
The Assessment of Osteoporosis Treatment in Post-menopausal Women
1 other identifier
interventional
500
1 country
2
Brief Summary
The study will be conducted to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2017
Longer than P75 for phase_4
2 active sites
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
First Submitted
Initial submission to the registry
December 16, 2016
CompletedFirst Posted
Study publicly available on registry
December 30, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJanuary 14, 2019
January 1, 2018
4.9 years
December 16, 2016
January 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain-derived neurotrophic factor
Serum brain-derived neurotrophic factor (BDNF) Levels
3 months
Secondary Outcomes (10)
Brain-derived neurotrophic factor
1 year
Vascular cell adhesion molecule-1
3 months
Orexin-A
3 months
Body components
3 months
Zung self-rating depression scale
3 months
- +5 more secondary outcomes
Study Arms (3)
Raloxifene group
EXPERIMENTALRaloxifene treatment
Comparator group
ACTIVE COMPARATORAlendronate treatment
Control group
NO INTERVENTIONTo refuse anti-osteoporosis treatment
Interventions
Alendronic acid 70mg with Colecalciferol 70mcg
Eligibility Criteria
You may qualify if:
- Postmenopausal female
- Osteoporosis
You may not qualify if:
- Psychological disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, 407, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2016
First Posted
December 30, 2016
Study Start
January 1, 2017
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
January 14, 2019
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share