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Osteoporosis Treatment in Post-menopausal Women

The Assessment of Osteoporosis Treatment in Post-menopausal Women

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03006003
Enrollment
500
Registered
2016-12-30
Start date
2017-01-01
Completion date
2021-12-31
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Syndrome

Keywords

Osteoporosis, Raloxifene, Central nervous disorders

Brief summary

The study will be conducted to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.

Detailed description

Fracture is one of the important complications in female. Osteoporosis should be treated in postmenopausal female due to high risk of fracture. Recently, there have been many classes of medications developed for preventing bone loss. Raloxifene, an oral form of anti-osteoporosis medication, has been reported to improved central nervous disorders. Therefore, this study is designed to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.

Interventions

DRUGRaloxifene

Raloxifene tratment more than 4 weeks

DRUGAlendronate

Alendronic acid 70mg with Colecalciferol 70mcg

Sponsors

Taichung Veterans General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Postmenopausal female * Osteoporosis

Exclusion criteria

* Psychological disorders

Design outcomes

Primary

MeasureTime frameDescription
Brain-derived neurotrophic factor3 monthsSerum brain-derived neurotrophic factor (BDNF) Levels

Secondary

MeasureTime frameDescription
Orexin-A3 monthsSerum Orexin-A levels
Body components3 monthsFat tissue ratio
Zung self-rating depression scale3 monthsQuestionnaire for depressive symptoms
5-Item Geriatric Depression Scale3 monthsQuestionnaire for Cognitive assessment
Vascular cell adhesion molecule-13 monthsSerum vascular cell adhesion molecule-1 (VCAM-1) levels
The Barthel index3 monthsQuestionnaire for Cognitive assessment
Instrumental Activities of Daily Living (IADL)3 monthsQuestionnaire for Cognitive assessment
ankle-brachial index3 monthsPeripheral artery disease assessment
Brain-derived neurotrophic factor1 yearSerum brain-derived neurotrophic factor (BDNF) Levels
The Mini Mental State Examination (MMSE)3 monthsQuestionnaire for Cognitive assessment

Countries

Taiwan

Contacts

Primary ContactI-Te Lee, MD, PhD
itlee@vghtc.gov.tw+886-4-23741300
Backup ContactI-Te Lee, MD, PhD
itlee@vghtc.gov.tw

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026