Bone Mineral Density Quantitative Trait Locus 7Phase 3NCT02179268
Antidepressants and Bone Mineral Density
A Phase 3 study testing sertraline, citalopram and venlafaxine in people with Bone Mineral Density Quantitative Trait Locus 7, run by Guiyang Medical University.
Trial summary
The aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and… Read more about this study
- Who is it for?
- Ages 20 to 48 years
- Conditions the study is for
- Bone Mineral Density Quantitative Trait Locus 7
- What is being tested?
- sertraline, citalopram and venlafaxine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 2014
- Phase
- Phase 3
- 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 to 48 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants needed to have a primary diagnosis of depression with Zung Self Rated Depression Scale (SDS) > 53, and Hamilton Depression Scale (HAMD) ≥20.
Who cannot join
- The patients with hyperparathyroidism, myeloma or other disorders known to affect bone metabolism
- Use of estrogen
- Calcitonin drugs
- Previous antidepressant or other psychiatric drug use or prior treatment history
About this study
Official title: International Committee of Medical Journal Editors
The aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and secondary endpoints being bone turnover markers.
Read the detailed description
These results have overt clinical implications. They suggest a noxious effect, particularly of selective serotonin reuptake inhibitor (SSRI) antidepressants, on bone. Osteoporosis and fracture is overtly the problem of the elderly. However, the process of skeletal consolidation begins in childhood and the corresponding phase of demineralisation proceeds at a glacial pace and lasts throughout adulthood, as a consequence antidepressant therapy is likely to have a substantive impact on a phenomenon likely to manifest decades hence. It is known that numerically small changes in bone mineral density are associated with a substantial increase in fracture risk. Because the SSRIs have only been in widespread use for two decades, it is plausible that the consequences of this adverse effect are yet to emerge. These data consequently suggest a recalibration of the risk/benefit ratio of this class of agents and additionally beg the question of the potential role of screening for bone mineral density in this at-risk population group.
- Being tested
- sertraline, citalopram, venlafaxine, reboxetine, control
- Keywords
- Antidepressants, bone mineral density, bone turnover markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Also called Zoloff
50mg, 50-150mg/d,qd for one year
citalopramDrug
Also called Cipramil
20mg, 20-40mg/d,qd,for one year
venlafaxineDrug
Also called Effexor
venlafaxine,25mg, 75-100mg/d, bid, for one year
reboxetineDrug
Also called Edronax
reboxetine,4mg, 4-8mg/d,qd for one year
controlBehavioural
Also called cognitive behavioral therapy
50min, every week for three months, every month, for nine months
| Study group | Role | What they receive |
|---|---|---|
| sertraline & control | Active comparator | sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months). Receives: Drug: sertraline; Drug: citalopram; Drug: venlafaxine; Drug: reboxetine; Behavioral: control |
| citalopram & Control | Active comparator | citalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months). Receives: Drug: sertraline; Drug: citalopram; Drug: venlafaxine; Drug: reboxetine; Behavioral: control |
| venlafaxine & control | Active comparator | venlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months). Receives: Drug: sertraline; Drug: citalopram; Drug: venlafaxine; Drug: reboxetine; Behavioral: control |
| reboxetine & control | Active comparator | reboxetine 4-8mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months). Receives: Drug: sertraline; Drug: citalopram; Drug: venlafaxine; Drug: reboxetine; Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density (BMD)
Measured: Change from Baseline in bone mineral density at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Mineral Density Quantitative Trait Locus 7Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guiyang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiming Wang, Guiyang Medical University
- Investigators
- yiming wang, Ph.D, Study chair, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179268
- Sponsor's protocol ID
- [2012] NO31260237/C090103
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Committee of Medical Journal Editors
- ClinicalTrials.gov ID
- NCT02179268
- Acronym / sponsor ID
- [2012] NO31260237/C090103
- Keywords
- Antidepressants, bone mineral density, bone turnover markers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Guiyang Medical UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Jul 2014 (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 aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and secondary endpoints being bone turnover markers.
Detailed description
These results have overt clinical implications. They suggest a noxious effect, particularly of selective serotonin reuptake inhibitor (SSRI) antidepressants, on bone. Osteoporosis and fracture is overtly the problem of the elderly. However, the process of skeletal consolidation begins in childhood and the corresponding phase of demineralisation proceeds at a glacial pace and lasts throughout adulthood, as a consequence antidepressant therapy is likely to have a substantive impact on a phenomenon likely to manifest decades hence. It is known that numerically small changes in bone mineral density are associated with a substantial increase in fracture risk. Because the SSRIs have only been in widespread use for two decades, it is plausible that the consequences of this adverse effect are yet to emerge. These data consequently suggest a recalibration of the risk/benefit ratio of this class of agents and additionally beg the question of the potential role of screening for bone mineral density in this at-risk population group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sertraline & control | Active comparator | Drug: sertraline, Drug: citalopram, Drug: venlafaxine, Drug: reboxetine, Behavioral: controlsertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months). |
| citalopram & Control | Active comparator | Drug: sertraline, Drug: citalopram, Drug: venlafaxine, Drug: reboxetine, Behavioral: controlcitalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months). |
| venlafaxine & control | Active comparator | Drug: sertraline, Drug: citalopram, Drug: venlafaxine, Drug: reboxetine, Behavioral: controlvenlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months). |
| reboxetine & control | Active comparator | Drug: sertraline, Drug: citalopram, Drug: venlafaxine, Drug: reboxetine, Behavioral: controlreboxetine 4-8mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months). |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants needed to have a primary diagnosis of depression with Zung Self Rated Depression Scale (SDS) > 53, and Hamilton Depression Scale (HAMD) ≥20.
Key exclusion criteria (4 listed)
- The patients with hyperparathyroidism, myeloma or other disorders known to affect bone metabolism
- Use of estrogen
- Calcitonin drugs
- Previous antidepressant or other psychiatric drug use or prior treatment history
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 |
|---|---|---|
| sertralineAlso: Zoloff50mg, 50-150mg/d,qd for one year | Drug | citalopram & Control, reboxetine & control, sertraline & control, venlafaxine & control |
| citalopramAlso: Cipramil20mg, 20-40mg/d,qd,for one year | Drug | citalopram & Control, reboxetine & control, sertraline & control, venlafaxine & control |
| venlafaxineAlso: Effexorvenlafaxine,25mg, 75-100mg/d, bid, for one year | Drug | citalopram & Control, reboxetine & control, sertraline & control, venlafaxine & control |
| reboxetineAlso: Edronaxreboxetine,4mg, 4-8mg/d,qd for one year | Drug | citalopram & Control, reboxetine & control, sertraline & control, venlafaxine & control |
| controlAlso: cognitive behavioral therapy50min, every week for three months, every month, for nine months | Behavioural | citalopram & Control, reboxetine & control, sertraline & control, venlafaxine & control |
Primary outcome
bone mineral density (BMD)
Time frame: Change from Baseline in bone mineral density at one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
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.
yiming wang, Ph.D study chair
World Health Organization
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sertraline, citalopram and venlafaxine in people with Bone Mineral Density Quantitative Trait Locus 7, run by Guiyang Medical University.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (BMD) (time frame: Change from Baseline in bone mineral density at one year). 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 1 Jul 2014.