BMDNCT03383861
Nutrition Status, BMD, and SSRIs
An observational study of BMD, run by University of New Mexico.
Trial summary
The association between selective serotonin reuptake inhibitor (SSRI) use and bone mass density (BMD) has been debated. Some have suggested features of depression, which SSRIs are prescribed to treat, may be a cause of decreased BMD, such as poor overall food intake at the time of SSRI use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- BMD
- What is being tested?
- Dual-Energy X-ray Absorptiometry (DXA)
- How many people
- 13,027 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NHANES participants
Who may be able to join
- Included adult NHANES participants are those who participated in the Dual-Energy X-ray Absorptiometry (DXA) femur-neck BMD test and responded in full to the demographic, pharmaceutical, and dietary surveys.
Who cannot join
- Pregnancy, incomplete survey responses, incomplete DXA results
About this study
Official title: Nutrition Status, Bone Mass Density, and Selective Serotonin Reuptake Inhibitors
The association between selective serotonin reuptake inhibitor (SSRI) use and bone mass density (BMD) has been debated. Some have suggested features of depression, which SSRIs are prescribed to treat, may be a cause of decreased BMD, such as poor overall food intake at the time of SSRI use. Our study seeks to determine whether SSRI use in adults is associated with lower than average BMD, and if there is an association between low micronutrient intake, SSRI use, and a low BMD.
- Conditions
- BMD
- Being tested
- Dual-Energy X-ray Absorptiometry (DXA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Energy X-ray Absorptiometry (DXA)Diagnostic test
BMD t-score derived from DXA scan
| Study group | Role | What they receive |
|---|---|---|
| SSRI long-term user | Adults, 655 with an SSRI prescription ≥180 days and identified in the National Health and Nutrition Examination Survey (NHANES) data. Receives: Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA) | |
| Non-user | Adults, 12,372 non-users, were identified in the National Health and Nutrition Examination Survey (NHANES) data. Receives: Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD t-score
Measured: NHANES DXA measurement taken 2005-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study startJan 2005
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: This is not a clinical trial and is only a retrospective chart review. This was inadvertently entered into the system as a clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BMDStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 13,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383861
- Sponsor's protocol ID
- 174318
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2017
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Status, Bone Mass Density, and Selective Serotonin Reuptake Inhibitors
- ClinicalTrials.gov ID
- NCT03383861
- Acronym / sponsor ID
- 174318
- Conditions
- BMD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This is not a clinical trial and is only a retrospective chart review. This was inadvertently entered into the system as a clinical trial.
- Enrolment
- 13,027 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Dec 2017 (actual)
- 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 association between selective serotonin reuptake inhibitor (SSRI) use and bone mass density (BMD) has been debated. Some have suggested features of depression, which SSRIs are prescribed to treat, may be a cause of decreased BMD, such as poor overall food intake at the time of SSRI use. Our study seeks to determine whether SSRI use in adults is associated with lower than average BMD, and if there is an association between low micronutrient intake, SSRI use, and a low BMD.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSRI long-term user | – | Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)Adults, 655 with an SSRI prescription ≥180 days and identified in the National Health and Nutrition Examination Survey (NHANES) data. |
| Non-user | – | Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)Adults, 12,372 non-users, were identified in the National Health and Nutrition Examination Survey (NHANES) data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NHANES participants
Key inclusion criteria (1 listed)
- Included adult NHANES participants are those who participated in the Dual-Energy X-ray Absorptiometry (DXA) femur-neck BMD test and responded in full to the demographic, pharmaceutical, and dietary surveys.
Key exclusion criteria (1 listed)
- Pregnancy, incomplete survey responses, incomplete DXA results
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 |
|---|---|---|
| Dual-Energy X-ray Absorptiometry (DXA)BMD t-score derived from DXA scan | Diagnostic test | Non-user, SSRI long-term user |
Primary outcome
BMD t-score
Time frame: NHANES DXA measurement taken 2005-2014
Results and safety
The study was stopped early (reason given: This is not a clinical trial and is only a retrospective chart review. This was inadvertently entered into the system as a clinical trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of BMD, run by University of New Mexico.
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 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: stopped early, as of the sponsor's last update on 10 Jan 2024. 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.
Are results available for this study?
The study was stopped early (reason given: This is not a clinical trial and is only a retrospective chart review. This was inadvertently entered into the system as a clinical trial.). Results are not available in the source record.
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?
BMD t-score (time frame: NHANES DXA measurement taken 2005-2014). 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 10 Jan 2024.