The Skeletal Effects of SSRIs
Conditions
Keywords
SSRI, serotonin transporter, DXA, pQCT, bone mass, adolescents
Brief 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.
Detailed description
Bone mass achieved by early adulthood is a major determinant of lifetime risk for osteoporosis. Therefore, optimizing peak bone mass is crucial to avoiding bone fracture with its associated morbidity and mortality. Emerging evidence suggests that serotonin plays a central role in bone metabolism. For example, preclinical experiments have shown that bone cells express the serotonin transporter and a variety of functional serotonin receptors whose activity modulates bone turnover. Epidemiologic studies have linked SSRIs to reduced bone mineral density and increased fracture risk in the elderly. SSRIs are widely used in youths to treat a number of psychiatric disorders. However, while their short-term efficacy and safety have been established, their long-term safety remains little investigated. The investigators aim to recruit, in a 2-year prospective observational study, 15 to 20 year-old participants upon the initiation of SSRI treatment. During the study period, bone mineral density of the lumbar spine and whole body will be measured using dual-energy x-ray absorptiometry (DXA) and of the radius using peripheral quantitative computed tomography (pQCT). A detailed psychiatric assessment will be conducted to control for psychopathology, as a potential confounding factor affecting bone mineralization. Changes in psychiatric treatment during the follow up period will also be documented and accounted for. By using a group of controls, of comparable age and sex distribution, the investigators aim to evaluate 1) whether psychopathology, at baseline, is associated with low bone mass, 2) if treatment with SSRIs suppresses bone mineralization, and 3) if the discontinuation of the SSRI is followed by a restoration of bone mineral accrual. 4) Furthermore, genetic testing will investigate whether variants of the serotonin system genes moderate the effect of SSRI treatment on bone mineral density. In sum, this work aims to improve the long-term safety of psychiatric treatments in order to optimize functioning and the quality of life of those who suffer from psychiatric disorders.
Interventions
None listed
Sponsors
National Institute of Mental Health (NIMH)
Chadi A. Calarge
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 15 to 20 years old (inclusive). 2. 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. 3. Ability to provide consent.
Exclusion criteria
1. Age- and sex-adjusted height Z-score \< -2 or \> 2. 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. 3. Presence of illicit drug and/or alcohol dependence. 4. Pregnancy. 5. Primary bone diseases (e.g., Paget's disease, osteogenesis imperfecta, rheumatoid arthritis). 6. 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). 7. Chronic disorders involving a vital organ (heart, lung, liver, kidney, brain) and congenital disorders. 8. Malnutrition conditions (e.g., chronic diarrhea, inflammatory bowel disease) or lead poisoning. 9. Chronic use of drugs affecting bone metabolism (e.g., oral corticosteroids). 10. Inability to cooperate with the BMD measurements. 11. Eating disorders, due to their potential effect on BMD. 12. If a senior in high school, plan to join an out-of-state college.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) | At baseline and every 8 months up to 2 years. | Whole-body dual energy x-ray absorptiometry (DXA) scan was obtained using a Hologic QDR DELPHI-4500A unit or a Hologic Discovery A unit (Hologic, Inc, Bedford, MA). The two DXA units were cross-calibrated. |
| Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | At baseline and every 4 months up to 2 years. | Volumetric bone mineral density (vBMD) at the nondominant radius (4% and 20% sites) was measured, at study entry and every four months, with peripheral quantitative computed tomography (pQCT), using a Stratec XCT-2000 scanner (Stratec, Inc., Pforzheim, Germany). Image analysis was performed using the manufacturer's software package, version 6.0. pQCT scans compromised by movement were rejected. Quality control and calibration of the equipment were performed daily. |
| Osteocalcin to C-terminal Telopeptide Ratio | At baseline and every 4 months up to 2 years. | Osteocalcin (ng/mL) is a bone formation marker and C-terminal telopeptide (ng/mL) a marker of bone resorption. |
| Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | At baseline and every 4 months up to 2 years. | Bone-specific alkaline phosphatase (ng/mL) is a marker of bone formation while C-terminal telopeptide (ng/mL) is a marker of bone resorption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cortical Volumetric BMD at 20% Radius | At baseline and every 4 months up to 2 years. | — |
| Cortical Thickness at 20% Radius | At baseline and every 4 months up to 2 years. | This is cortical thickness as measured by pQCT. |
| Lumbar Spine Bone Mineral Density (BMD) Z-score | At baseline and every 8 months up to 2 years. | This is a Z-score adjusted for sex, age, race, and height. |
Countries
United States
Participant flow
Recruitment details
Between 09/2010 and 12/2014, 287 participants were recruited into this longitudinal observational study, from outpatient and inpatient clinical settings as well as by advertisement and word of mouth. However, 23 of them either did not complete their intake visit or had to be excluded due to discovery of exclusionary conditions.
Pre-assignment details
within one month of starting a SSRI or taking no psychotropics
Participants by arm
| Arm | Count |
|---|---|
| SSRI Group Participants within one month of starting an SSRI | 127 |
| Unmedicated Group No treatment with SSRIs | 137 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 28 | 15 |
| Overall Study | Moved out of state | 3 | 3 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Pregnancy | 6 | 0 |
| Overall Study | Study Burden | 11 | 7 |
Baseline characteristics
| Characteristic | SSRI Group | Total | Unmedicated Group |
|---|---|---|---|
| Age, Continuous | 18.8 years STANDARD_DEVIATION 1.7 | 18.9 years STANDARD_DEVIATION 1.6 | 19.0 years STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 22 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 242 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 15 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 114 Participants | 233 Participants | 119 Participants |
| Region of Enrollment United States | 127 Participants | 264 Participants | 137 Participants |
| Sex: Female, Male Female | 83 Participants | 159 Participants | 76 Participants |
| Sex: Female, Male Male | 44 Participants | 105 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 127 | 0 / 137 |
| other Total, other adverse events | 19 / 127 | 27 / 137 |
| serious Total, serious adverse events | 0 / 127 | 1 / 137 |
Outcome results
Primary
Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio
Bone-specific alkaline phosphatase (ng/mL) is a marker of bone formation while C-terminal telopeptide (ng/mL) is a marker of bone resorption.
Time frame: At baseline and every 4 months up to 2 years.
Population: The figures below might be less than the stated numbers above depending on availability of serum samples, the performance of the assay, and premature attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SSRI Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 8 Months | 51.9 Ratio | Standard Deviation 16.9 |
| SSRI Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 16 Months | 52.7 Ratio | Standard Deviation 18.7 |
| SSRI Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 4 Months | 54.8 Ratio | Standard Deviation 34.4 |
| SSRI Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 20 Months | 46.8 Ratio | Standard Deviation 14.3 |
| SSRI Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 12 Months | 54.2 Ratio | Standard Deviation 22.6 |
| SSRI Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 24 Months | 56.0 Ratio | Standard Deviation 22.4 |
| SSRI Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | Baseline | 49.4 Ratio | Standard Deviation 16.4 |
| Unmedicated Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 24 Months | 47.3 Ratio | Standard Deviation 14.9 |
| Unmedicated Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | Baseline | 50.3 Ratio | Standard Deviation 18.6 |
| Unmedicated Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 4 Months | 46.5 Ratio | Standard Deviation 16.3 |
| Unmedicated Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 8 Months | 48.9 Ratio | Standard Deviation 16.1 |
| Unmedicated Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 12 Months | 47.2 Ratio | Standard Deviation 18.1 |
| Unmedicated Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 16 Months | 51.4 Ratio | Standard Deviation 21.1 |
| Unmedicated Group | Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio | 20 Months | 50.0 Ratio | Standard Deviation 20.9 |
Primary
Osteocalcin to C-terminal Telopeptide Ratio
Osteocalcin (ng/mL) is a bone formation marker and C-terminal telopeptide (ng/mL) a marker of bone resorption.
Time frame: At baseline and every 4 months up to 2 years.
Population: The figures below may be lower based on availability of serum, performance of the assay, and premature attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SSRI Group | Osteocalcin to C-terminal Telopeptide Ratio | 8 Months | 49.7 Ratio | Standard Deviation 17.1 |
| SSRI Group | Osteocalcin to C-terminal Telopeptide Ratio | 16 Months | 51.9 Ratio | Standard Deviation 17.9 |
| SSRI Group | Osteocalcin to C-terminal Telopeptide Ratio | 4 Months | 53.9 Ratio | Standard Deviation 33.6 |
| SSRI Group | Osteocalcin to C-terminal Telopeptide Ratio | 20 Months | 46.8 Ratio | Standard Deviation 14.2 |
| SSRI Group | Osteocalcin to C-terminal Telopeptide Ratio | 12 Months | 53.4 Ratio | Standard Deviation 22.8 |
| SSRI Group | Osteocalcin to C-terminal Telopeptide Ratio | 24 Months | 54.5 Ratio | Standard Deviation 21.7 |
| SSRI Group | Osteocalcin to C-terminal Telopeptide Ratio | Baseline | 49.1 Ratio | Standard Deviation 16.4 |
| Unmedicated Group | Osteocalcin to C-terminal Telopeptide Ratio | 24 Months | 48.0 Ratio | Standard Deviation 16.5 |
| Unmedicated Group | Osteocalcin to C-terminal Telopeptide Ratio | Baseline | 50.4 Ratio | Standard Deviation 18.7 |
| Unmedicated Group | Osteocalcin to C-terminal Telopeptide Ratio | 4 Months | 47.2 Ratio | Standard Deviation 17.3 |
| Unmedicated Group | Osteocalcin to C-terminal Telopeptide Ratio | 8 Months | 49.1 Ratio | Standard Deviation 18.2 |
| Unmedicated Group | Osteocalcin to C-terminal Telopeptide Ratio | 12 Months | 47.2 Ratio | Standard Deviation 18.1 |
| Unmedicated Group | Osteocalcin to C-terminal Telopeptide Ratio | 16 Months | 50.3 Ratio | Standard Deviation 20.9 |
| Unmedicated Group | Osteocalcin to C-terminal Telopeptide Ratio | 20 Months | 50.3 Ratio | Standard Deviation 20.8 |
Primary
Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race)
Whole-body dual energy x-ray absorptiometry (DXA) scan was obtained using a Hologic QDR DELPHI-4500A unit or a Hologic Discovery A unit (Hologic, Inc, Bedford, MA). The two DXA units were cross-calibrated.
Time frame: At baseline and every 8 months up to 2 years.
Population: These are the starting sample size but the figures below reflect participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SSRI Group | Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) | Baseline | 0.35 Z score (age-sex-height-race specific) | Standard Deviation 0.84 |
| SSRI Group | Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) | 8 Months | 0.36 Z score (age-sex-height-race specific) | Standard Deviation 0.84 |
| SSRI Group | Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) | 16 Months | 0.32 Z score (age-sex-height-race specific) | Standard Deviation 0.87 |
| SSRI Group | Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) | 24 Months | 0.32 Z score (age-sex-height-race specific) | Standard Deviation 0.9 |
| Unmedicated Group | Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) | 24 Months | 0.41 Z score (age-sex-height-race specific) | Standard Deviation 0.87 |
| Unmedicated Group | Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) | Baseline | 0.43 Z score (age-sex-height-race specific) | Standard Deviation 0.9 |
| Unmedicated Group | Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) | 16 Months | 0.47 Z score (age-sex-height-race specific) | Standard Deviation 0.9 |
| Unmedicated Group | Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race) | 8 Months | 0.44 Z score (age-sex-height-race specific) | Standard Deviation 0.92 |
Primary
Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius
Volumetric bone mineral density (vBMD) at the nondominant radius (4% and 20% sites) was measured, at study entry and every four months, with peripheral quantitative computed tomography (pQCT), using a Stratec XCT-2000 scanner (Stratec, Inc., Pforzheim, Germany). Image analysis was performed using the manufacturer's software package, version 6.0. pQCT scans compromised by movement were rejected. Quality control and calibration of the equipment were performed daily.
Time frame: At baseline and every 4 months up to 2 years.
Population: This was the starting sample size. However, the figures below reflect participant attrition and exclusion of scans due to movement artifact.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SSRI Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 8 Months | 217.9 mg/cm^3 | Standard Deviation 40.2 |
| SSRI Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 16 Months | 216.5 mg/cm^3 | Standard Deviation 40.3 |
| SSRI Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 4 Months | 212.9 mg/cm^3 | Standard Deviation 40.7 |
| SSRI Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 20 Months | 213.6 mg/cm^3 | Standard Deviation 41.9 |
| SSRI Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 12 Months | 213.6 mg/cm^3 | Standard Deviation 42.9 |
| SSRI Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 24 Months | 209.1 mg/cm^3 | Standard Deviation 40.48 |
| SSRI Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | Baseline | 213.7 mg/cm^3 | Standard Deviation 37.7 |
| Unmedicated Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 24 Months | 221.7 mg/cm^3 | Standard Deviation 37.1 |
| Unmedicated Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | Baseline | 220.7 mg/cm^3 | Standard Deviation 35 |
| Unmedicated Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 4 Months | 220.0 mg/cm^3 | Standard Deviation 37.8 |
| Unmedicated Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 8 Months | 220.8 mg/cm^3 | Standard Deviation 39.5 |
| Unmedicated Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 12 Months | 218.9 mg/cm^3 | Standard Deviation 38.9 |
| Unmedicated Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 16 Months | 220.9 mg/cm^3 | Standard Deviation 41.1 |
| Unmedicated Group | Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius | 20 Months | 218.7 mg/cm^3 | Standard Deviation 39.4 |
Secondary
Cortical Thickness at 20% Radius
This is cortical thickness as measured by pQCT.
Time frame: At baseline and every 4 months up to 2 years.
Population: The figures below may be lower than the overall numbers above due to exclusions for movement artifacts and premature drop outs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SSRI Group | Cortical Thickness at 20% Radius | 16 Months | 2.72 mm | Standard Deviation 0.31 |
| SSRI Group | Cortical Thickness at 20% Radius | 24 Months | 2.67 mm | Standard Deviation 0.3 |
| SSRI Group | Cortical Thickness at 20% Radius | 12 Months | 2.69 mm | Standard Deviation 0.33 |
| SSRI Group | Cortical Thickness at 20% Radius | Baseline | 2.70 mm | Standard Deviation 0.34 |
| SSRI Group | Cortical Thickness at 20% Radius | 20 Months | 2.72 mm | Standard Deviation 0.33 |
| SSRI Group | Cortical Thickness at 20% Radius | 4 Months | 2.68 mm | Standard Deviation 0.32 |
| SSRI Group | Cortical Thickness at 20% Radius | 8 Months | 2.72 mm | Standard Deviation 0.34 |
| Unmedicated Group | Cortical Thickness at 20% Radius | 4 Months | 2.80 mm | Standard Deviation 0.34 |
| Unmedicated Group | Cortical Thickness at 20% Radius | 8 Months | 2.83 mm | Standard Deviation 0.36 |
| Unmedicated Group | Cortical Thickness at 20% Radius | 12 Months | 2.82 mm | Standard Deviation 0.36 |
| Unmedicated Group | Cortical Thickness at 20% Radius | 16 Months | 2.81 mm | Standard Deviation 0.36 |
| Unmedicated Group | Cortical Thickness at 20% Radius | 20 Months | 2.79 mm | Standard Deviation 0.35 |
| Unmedicated Group | Cortical Thickness at 20% Radius | 24 Months | 2.84 mm | Standard Deviation 0.38 |
| Unmedicated Group | Cortical Thickness at 20% Radius | Baseline | 2.80 mm | Standard Deviation 0.35 |
Secondary
Cortical Volumetric BMD at 20% Radius
Time frame: At baseline and every 4 months up to 2 years.
Population: This was the original sample size per group but the figures below reflect attrition and data exclusion due to movement artifacts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SSRI Group | Cortical Volumetric BMD at 20% Radius | 4 Months | 1159.8 mg/cm^3 | Standard Deviation 29.9 |
| SSRI Group | Cortical Volumetric BMD at 20% Radius | 16 Months | 1170.1 mg/cm^3 | Standard Deviation 22.6 |
| SSRI Group | Cortical Volumetric BMD at 20% Radius | 8 Months | 1163.1 mg/cm^3 | Standard Deviation 26.7 |
| SSRI Group | Cortical Volumetric BMD at 20% Radius | 20 Months | 1172.8 mg/cm^3 | Standard Deviation 27.2 |
| SSRI Group | Cortical Volumetric BMD at 20% Radius | Baseline | 1155.6 mg/cm^3 | Standard Deviation 33 |
| SSRI Group | Cortical Volumetric BMD at 20% Radius | 24 Months | 1173.4 mg/cm^3 | Standard Deviation 23 |
| SSRI Group | Cortical Volumetric BMD at 20% Radius | 12 Months | 1168.3 mg/cm^3 | Standard Deviation 26.5 |
| Unmedicated Group | Cortical Volumetric BMD at 20% Radius | 24 Months | 1170.5 mg/cm^3 | Standard Deviation 25.4 |
| Unmedicated Group | Cortical Volumetric BMD at 20% Radius | Baseline | 1156.2 mg/cm^3 | Standard Deviation 34.5 |
| Unmedicated Group | Cortical Volumetric BMD at 20% Radius | 8 Months | 1164.7 mg/cm^3 | Standard Deviation 28.5 |
| Unmedicated Group | Cortical Volumetric BMD at 20% Radius | 12 Months | 1166.8 mg/cm^3 | Standard Deviation 27.1 |
| Unmedicated Group | Cortical Volumetric BMD at 20% Radius | 16 Months | 1169.5 mg/cm^3 | Standard Deviation 24.9 |
| Unmedicated Group | Cortical Volumetric BMD at 20% Radius | 20 Months | 1173.1 mg/cm^3 | Standard Deviation 22.7 |
| Unmedicated Group | Cortical Volumetric BMD at 20% Radius | 4 Months | 1161.7 mg/cm^3 | Standard Deviation 29.5 |
Secondary
Lumbar Spine Bone Mineral Density (BMD) Z-score
This is a Z-score adjusted for sex, age, race, and height.
Time frame: At baseline and every 8 months up to 2 years.
Population: This was the initial sample size per group but the figures below reflect attrition or data excluded due to artifact.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SSRI Group | Lumbar Spine Bone Mineral Density (BMD) Z-score | Baseline | -0.00 Z-score (Age-Sex-Height-Race Specific) | Standard Deviation 1.03 |
| SSRI Group | Lumbar Spine Bone Mineral Density (BMD) Z-score | 8 Months | 0.01 Z-score (Age-Sex-Height-Race Specific) | Standard Deviation 1.06 |
| SSRI Group | Lumbar Spine Bone Mineral Density (BMD) Z-score | 16 Months | -0.02 Z-score (Age-Sex-Height-Race Specific) | Standard Deviation 1.19 |
| SSRI Group | Lumbar Spine Bone Mineral Density (BMD) Z-score | 24 Months | 0.03 Z-score (Age-Sex-Height-Race Specific) | Standard Deviation 1.18 |
| Unmedicated Group | Lumbar Spine Bone Mineral Density (BMD) Z-score | 24 Months | 0.09 Z-score (Age-Sex-Height-Race Specific) | Standard Deviation 1.06 |
| Unmedicated Group | Lumbar Spine Bone Mineral Density (BMD) Z-score | Baseline | 0.09 Z-score (Age-Sex-Height-Race Specific) | Standard Deviation 1.09 |
| Unmedicated Group | Lumbar Spine Bone Mineral Density (BMD) Z-score | 16 Months | 0.11 Z-score (Age-Sex-Height-Race Specific) | Standard Deviation 1.17 |
| Unmedicated Group | Lumbar Spine Bone Mineral Density (BMD) Z-score | 8 Months | 0.13 Z-score (Age-Sex-Height-Race Specific) | Standard Deviation 1.09 |