N/A
N=264
Do Serotonin Reuptake Inhibitors (SSRIs) Affect Bone Mass in Adolescents
The Skeletal Effects of SSRIs
Bottom Line
View on ClinicalTrials.gov: NCT02147184 ↗Enrolled (actual)
264
Serious AEs
0.4%
Results posted
Oct 2017
Primary outcome: Primary: Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) — 0.35; 0.43; 0.36; 0.44 Z score (age-sex-height-race specific)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Chadi A. Calarge
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) |
0.35; 0.43; 0.36; 0.44; 0.32; 0.47 | — |
| PRIMARY Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius |
213.7; 220.7; 212.9; 220.0; 217.9; 220.8 | — |
| PRIMARY Osteocalcin to C-terminal Telopeptide Ratio |
49.1; 50.4; 53.9; 47.2; 49.7; 49.1 | — |
| PRIMARY Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio |
49.4; 50.3; 54.8; 46.5; 51.9; 48.9 | — |
| SECONDARY Lumbar Spine Bone Mineral Density (BMD) Z-score |
-0.00; 0.09; 0.01; 0.13; -0.02; 0.11 | — |
| SECONDARY Cortical Volumetric BMD at 20% Radius |
1155.6; 1156.2; 1159.8; 1161.7; 1163.1; 1164.7 | — |
| SECONDARY Cortical Thickness at 20% Radius |
2.70; 2.80; 2.68; 2.80; 2.72; 2.83 | — |
Summary
Building on findings from animal studies, pediatric clinical trials, epidemiologic research in adults, and on preliminary findings from the investigators' laboratory in children and adolescents, this project aims to investigate whether selective serotonin reuptake inhibitors (SSRIs), a group of widely-used psychotropics, are associated with impaired bone mineralization in youths. Establishing such an association is a first step in a process that would eventually involve developing preventative interventions. Identifying genetic factors that place certain youths at higher risks for this side effect would ultimately allow clinicians to tailor treatment to the needs and vulnerabilities of each youth, moving the field closer towards individualized medicine.
Eligibility Criteria
Inclusion Criteria
- Age 15 to 20 years old (inclusive).
- Treatment with an SSRI, regardless of the indication, having been started within one month. This criterion does not apply to controls. SSRIs include: fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine.
- Ability to provide consent.
Exclusion Criteria
- Age- and sex-adjusted height Z-score 2.
- Concomitant treatment with other antidepressants, psychostimulants, or mood stabilizers and antipsychotics. Treatment with benzodiazepines, low dose trazodone, alpha-2 agonists, and antihistaminergic agents will be allowed.
- Presence of illicit drug and/or alcohol dependence.
- Pregnancy.
- Primary bone diseases (e.g., Paget's disease, osteogenesis imperfecta, rheumatoid arthritis).
- Potential secondary bone disease (e.g., due to chronic inflammatory diseases, diabetes, hypo- or hyperparathyroidism, hyperthyroidism, growth hormone deficiency, and other endocrine disturbances, history of childhood cancer, or prior transplantation).
- Chronic disorders involving a vital organ (heart, lung, liver, kidney, brain) and congenital disorders.
- Malnutrition conditions (e.g., chronic diarrhea, inflammatory bowel disease) or lead poisoning.
- Chronic use of drugs affecting bone metabolism (e.g., oral corticosteroids).
- Inability to cooperate with the BMD measurements.
- Eating disorders, due to their potential effect on BMD.
- If a senior in high school, plan to join an out-of-state college.
Data sourced from ClinicalTrials.gov (NCT02147184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.