Depressive SyndromePhase 4NCT03006003
Osteoporosis Treatment in Post-menopausal Women
A Phase 4 study testing Raloxifene and Alendronate in people with Depressive Syndrome, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
Trial summary
The study will be conducted to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Depressive Syndrome
- What is being tested?
- Raloxifene and Alendronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Jan 2017to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal female
- Osteoporosis
Who cannot join
- Psychological disorders
Trial locations and contacts
2 sites in 1 country.
I-Te Lee, MD, PhD contact
Taiwan2 sites, 2 recruiting
- Recruiting
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, 407
I Te Lee, MD, 886-4-23741340, itlee@vghtc.gov.tw
I Te Lee, MD
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
I-Te Lee, MD, PhD
About this study
Official title: The Assessment of Osteoporosis Treatment in Post-menopausal Women
The study will be conducted to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.
Read the 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.
- Conditions
- Depressive Syndrome
- Being tested
- Raloxifene, Alendronate
- Keywords
- Osteoporosis, Raloxifene, Central nervous disorders
- Medical subject headings
- Depressive Disorder, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaloxifeneDrug
Also called Evista
Raloxifene tratment more than 4 weeks
AlendronateDrug
Also called FOSAMAX PLUS
Alendronic acid 70mg with Colecalciferol 70mcg
| Study group | Role | What they receive |
|---|---|---|
| Raloxifene group | Experimental | Raloxifene treatment Receives: Drug: Raloxifene |
| Comparator group | Active comparator | Alendronate treatment Receives: Drug: Alendronate |
| Control group | No intervention | To refuse anti-osteoporosis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain-derived neurotrophic factor
Serum brain-derived neurotrophic factor (BDNF) Levels
Measured: 3 months
Secondary outcomes (10)
Brain-derived neurotrophic factor
Serum brain-derived neurotrophic factor (BDNF) Levels
Measured: 1 year
Vascular cell adhesion molecule-1
Serum vascular cell adhesion molecule-1 (VCAM-1) levels
Measured: 3 months
Orexin-A
Serum Orexin-A levels
Measured: 3 months
Body components
Fat tissue ratio
Measured: 3 months
Zung self-rating depression scale
Questionnaire for depressive symptoms
Measured: 3 months
5-Item Geriatric Depression Scale
Questionnaire for Cognitive assessment
Measured: 3 months
The Mini Mental State Examination (MMSE)
Questionnaire for Cognitive assessment
Measured: 3 months
The Barthel index
Questionnaire for Cognitive assessment
Measured: 3 months
Instrumental Activities of Daily Living (IADL)
Questionnaire for Cognitive assessment
Measured: 3 months
ankle-brachial index
Peripheral artery disease assessment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start1 Jan 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SyndromeStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006003
- Sponsor's protocol ID
- CE16256A
- Status last verified
- Jan 2018
- First submitted
- 16 Dec 2016
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Osteoporosis Treatment in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT03006003
- Acronym / sponsor ID
- CE16256A
- Conditions
- Depressive Syndrome
- Keywords
- Osteoporosis, Raloxifene, Central nervous disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Raloxifene group | Experimental | Drug: RaloxifeneRaloxifene treatment |
| Comparator group | Active comparator | Drug: AlendronateAlendronate treatment |
| Control group | No intervention | –To refuse anti-osteoporosis treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal female
- Osteoporosis
Key exclusion criteria (1 listed)
- Psychological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaloxifeneAlso: EvistaRaloxifene tratment more than 4 weeks | Drug | Raloxifene group |
| AlendronateAlso: FOSAMAX PLUSAlendronic acid 70mg with Colecalciferol 70mcg | Drug | Comparator group |
Primary outcome
Brain-derived neurotrophic factor
Time frame: 3 months
Serum brain-derived neurotrophic factor (BDNF) Levels
10 secondary outcomes
Brain-derived neurotrophic factor
Time frame: 1 year
Vascular cell adhesion molecule-1
Time frame: 3 months
Orexin-A
Time frame: 3 months
Body components
Time frame: 3 months
Zung self-rating depression scale
Time frame: 3 months
5-Item Geriatric Depression Scale
Time frame: 3 months
The Mini Mental State Examination (MMSE)
Time frame: 3 months
The Barthel index
Time frame: 3 months
Instrumental Activities of Daily Living (IADL)
Time frame: 3 months
ankle-brachial index
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Te Lee, MD, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raloxifene and Alendronate in people with Depressive Syndrome, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Te Lee, MD, PhD (+886-4-23741300, itlee@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain-derived neurotrophic factor (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.