Trial Outcomes & Findings for Do Serotonin Reuptake Inhibitors (SSRIs) Affect Bone Mass in Adolescents (NCT NCT02147184)
NCT ID: NCT02147184
Last Updated: 2023-06-28
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
287 participants
Primary outcome timeframe
At baseline and every 8 months up to 2 years.
Results posted on
2023-06-28
Participant Flow
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.
within one month of starting a SSRI or taking no psychotropics
Participant milestones
| Measure |
SSRI Group
Participants within one month of starting an SSRI
|
Unmedicated Group
No treatment with SSRIs
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
137
|
|
Overall Study
COMPLETED
|
78
|
110
|
|
Overall Study
NOT COMPLETED
|
49
|
27
|
Reasons for withdrawal
| Measure |
SSRI Group
Participants within one month of starting an SSRI
|
Unmedicated Group
No treatment with SSRIs
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
28
|
15
|
|
Overall Study
Study Burden
|
11
|
7
|
|
Overall Study
Pregnancy
|
6
|
0
|
|
Overall Study
Moved out of state
|
3
|
3
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Do Serotonin Reuptake Inhibitors (SSRIs) Affect Bone Mass in Adolescents
Baseline characteristics by cohort
| Measure |
SSRI Group
n=127 Participants
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 Participants
No treatment with SSRIs
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.8 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
19.0 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
18.9 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and every 8 months up to 2 years.Population: These are the starting sample size but the figures below reflect participant attrition.
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.
Outcome measures
| Measure |
SSRI Group
n=127 Participants
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 Participants
No treatment with SSRIs
|
|---|---|---|
|
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
|
0.43 Z score (age-sex-height-race specific)
Standard Deviation 0.90
|
|
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
|
0.44 Z score (age-sex-height-race specific)
Standard Deviation 0.92
|
|
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
|
0.47 Z score (age-sex-height-race specific)
Standard Deviation 0.90
|
|
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 0.90
|
0.41 Z score (age-sex-height-race specific)
Standard Deviation 0.87
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
SSRI Group
n=127 Participants
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 Participants
No treatment with SSRIs
|
|---|---|---|
|
Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius
Baseline
|
213.7 mg/cm^3
Standard Deviation 37.7
|
220.7 mg/cm^3
Standard Deviation 35.0
|
|
Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius
4 Months
|
212.9 mg/cm^3
Standard Deviation 40.7
|
220.0 mg/cm^3
Standard Deviation 37.8
|
|
Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius
8 Months
|
217.9 mg/cm^3
Standard Deviation 40.2
|
220.8 mg/cm^3
Standard Deviation 39.5
|
|
Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius
12 Months
|
213.6 mg/cm^3
Standard Deviation 42.9
|
218.9 mg/cm^3
Standard Deviation 38.9
|
|
Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius
16 Months
|
216.5 mg/cm^3
Standard Deviation 40.3
|
220.9 mg/cm^3
Standard Deviation 41.1
|
|
Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius
20 Months
|
213.6 mg/cm^3
Standard Deviation 41.9
|
218.7 mg/cm^3
Standard Deviation 39.4
|
|
Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius
24 Months
|
209.1 mg/cm^3
Standard Deviation 40.48
|
221.7 mg/cm^3
Standard Deviation 37.1
|
PRIMARY outcome
Timeframe: 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.
Osteocalcin (ng/mL) is a bone formation marker and C-terminal telopeptide (ng/mL) a marker of bone resorption.
Outcome measures
| Measure |
SSRI Group
n=127 Participants
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 Participants
No treatment with SSRIs
|
|---|---|---|
|
Osteocalcin to C-terminal Telopeptide Ratio
Baseline
|
49.1 Ratio
Standard Deviation 16.4
|
50.4 Ratio
Standard Deviation 18.7
|
|
Osteocalcin to C-terminal Telopeptide Ratio
4 Months
|
53.9 Ratio
Standard Deviation 33.6
|
47.2 Ratio
Standard Deviation 17.3
|
|
Osteocalcin to C-terminal Telopeptide Ratio
8 Months
|
49.7 Ratio
Standard Deviation 17.1
|
49.1 Ratio
Standard Deviation 18.2
|
|
Osteocalcin to C-terminal Telopeptide Ratio
12 Months
|
53.4 Ratio
Standard Deviation 22.8
|
47.2 Ratio
Standard Deviation 18.1
|
|
Osteocalcin to C-terminal Telopeptide Ratio
16 Months
|
51.9 Ratio
Standard Deviation 17.9
|
50.3 Ratio
Standard Deviation 20.9
|
|
Osteocalcin to C-terminal Telopeptide Ratio
20 Months
|
46.8 Ratio
Standard Deviation 14.2
|
50.3 Ratio
Standard Deviation 20.8
|
|
Osteocalcin to C-terminal Telopeptide Ratio
24 Months
|
54.5 Ratio
Standard Deviation 21.7
|
48.0 Ratio
Standard Deviation 16.5
|
PRIMARY outcome
Timeframe: 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.
Bone-specific alkaline phosphatase (ng/mL) is a marker of bone formation while C-terminal telopeptide (ng/mL) is a marker of bone resorption.
Outcome measures
| Measure |
SSRI Group
n=127 Participants
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 Participants
No treatment with SSRIs
|
|---|---|---|
|
Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio
Baseline
|
49.4 Ratio
Standard Deviation 16.4
|
50.3 Ratio
Standard Deviation 18.6
|
|
Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio
4 Months
|
54.8 Ratio
Standard Deviation 34.4
|
46.5 Ratio
Standard Deviation 16.3
|
|
Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio
8 Months
|
51.9 Ratio
Standard Deviation 16.9
|
48.9 Ratio
Standard Deviation 16.1
|
|
Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio
12 Months
|
54.2 Ratio
Standard Deviation 22.6
|
47.2 Ratio
Standard Deviation 18.1
|
|
Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio
16 Months
|
52.7 Ratio
Standard Deviation 18.7
|
51.4 Ratio
Standard Deviation 21.1
|
|
Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio
20 Months
|
46.8 Ratio
Standard Deviation 14.3
|
50.0 Ratio
Standard Deviation 20.9
|
|
Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio
24 Months
|
56.0 Ratio
Standard Deviation 22.4
|
47.3 Ratio
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: 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.
This is a Z-score adjusted for sex, age, race, and height.
Outcome measures
| Measure |
SSRI Group
n=127 Participants
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 Participants
No treatment with SSRIs
|
|---|---|---|
|
Lumbar Spine Bone Mineral Density (BMD) Z-score
Baseline
|
-0.00 Z-score (Age-Sex-Height-Race Specific)
Standard Deviation 1.03
|
0.09 Z-score (Age-Sex-Height-Race Specific)
Standard Deviation 1.09
|
|
Lumbar Spine Bone Mineral Density (BMD) Z-score
8 Months
|
0.01 Z-score (Age-Sex-Height-Race Specific)
Standard Deviation 1.06
|
0.13 Z-score (Age-Sex-Height-Race Specific)
Standard Deviation 1.09
|
|
Lumbar Spine Bone Mineral Density (BMD) Z-score
16 Months
|
-0.02 Z-score (Age-Sex-Height-Race Specific)
Standard Deviation 1.19
|
0.11 Z-score (Age-Sex-Height-Race Specific)
Standard Deviation 1.17
|
|
Lumbar Spine Bone Mineral Density (BMD) Z-score
24 Months
|
0.03 Z-score (Age-Sex-Height-Race Specific)
Standard Deviation 1.18
|
0.09 Z-score (Age-Sex-Height-Race Specific)
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SSRI Group
n=127 Participants
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 Participants
No treatment with SSRIs
|
|---|---|---|
|
Cortical Volumetric BMD at 20% Radius
Baseline
|
1155.6 mg/cm^3
Standard Deviation 33.0
|
1156.2 mg/cm^3
Standard Deviation 34.5
|
|
Cortical Volumetric BMD at 20% Radius
4 Months
|
1159.8 mg/cm^3
Standard Deviation 29.9
|
1161.7 mg/cm^3
Standard Deviation 29.5
|
|
Cortical Volumetric BMD at 20% Radius
8 Months
|
1163.1 mg/cm^3
Standard Deviation 26.7
|
1164.7 mg/cm^3
Standard Deviation 28.5
|
|
Cortical Volumetric BMD at 20% Radius
12 Months
|
1168.3 mg/cm^3
Standard Deviation 26.5
|
1166.8 mg/cm^3
Standard Deviation 27.1
|
|
Cortical Volumetric BMD at 20% Radius
16 Months
|
1170.1 mg/cm^3
Standard Deviation 22.6
|
1169.5 mg/cm^3
Standard Deviation 24.9
|
|
Cortical Volumetric BMD at 20% Radius
20 Months
|
1172.8 mg/cm^3
Standard Deviation 27.2
|
1173.1 mg/cm^3
Standard Deviation 22.7
|
|
Cortical Volumetric BMD at 20% Radius
24 Months
|
1173.4 mg/cm^3
Standard Deviation 23.0
|
1170.5 mg/cm^3
Standard Deviation 25.4
|
SECONDARY outcome
Timeframe: 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.
This is cortical thickness as measured by pQCT.
Outcome measures
| Measure |
SSRI Group
n=127 Participants
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 Participants
No treatment with SSRIs
|
|---|---|---|
|
Cortical Thickness at 20% Radius
Baseline
|
2.70 mm
Standard Deviation 0.34
|
2.80 mm
Standard Deviation 0.35
|
|
Cortical Thickness at 20% Radius
4 Months
|
2.68 mm
Standard Deviation 0.32
|
2.80 mm
Standard Deviation 0.34
|
|
Cortical Thickness at 20% Radius
8 Months
|
2.72 mm
Standard Deviation 0.34
|
2.83 mm
Standard Deviation 0.36
|
|
Cortical Thickness at 20% Radius
12 Months
|
2.69 mm
Standard Deviation 0.33
|
2.82 mm
Standard Deviation 0.36
|
|
Cortical Thickness at 20% Radius
16 Months
|
2.72 mm
Standard Deviation 0.31
|
2.81 mm
Standard Deviation 0.36
|
|
Cortical Thickness at 20% Radius
20 Months
|
2.72 mm
Standard Deviation 0.33
|
2.79 mm
Standard Deviation 0.35
|
|
Cortical Thickness at 20% Radius
24 Months
|
2.67 mm
Standard Deviation 0.30
|
2.84 mm
Standard Deviation 0.38
|
Adverse Events
SSRI Group
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Unmedicated Group
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SSRI Group
n=127 participants at risk
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 participants at risk
No treatment with SSRIs
|
|---|---|---|
|
Cardiac disorders
Fainting
|
0.00%
0/127 • 2 years.
This was not a clinical intervention. Adverse events were simply related to participating in a study.
|
0.73%
1/137 • Number of events 1 • 2 years.
This was not a clinical intervention. Adverse events were simply related to participating in a study.
|
Other adverse events
| Measure |
SSRI Group
n=127 participants at risk
Participants within one month of starting an SSRI
|
Unmedicated Group
n=137 participants at risk
No treatment with SSRIs
|
|---|---|---|
|
Blood and lymphatic system disorders
Multiple blood draws required
|
7.9%
10/127 • Number of events 10 • 2 years.
This was not a clinical intervention. Adverse events were simply related to participating in a study.
|
12.4%
17/137 • Number of events 17 • 2 years.
This was not a clinical intervention. Adverse events were simply related to participating in a study.
|
|
Cardiac disorders
Lightheadedness
|
4.7%
6/127 • Number of events 7 • 2 years.
This was not a clinical intervention. Adverse events were simply related to participating in a study.
|
6.6%
9/137 • Number of events 9 • 2 years.
This was not a clinical intervention. Adverse events were simply related to participating in a study.
|
|
Cardiac disorders
Syncope
|
2.4%
3/127 • Number of events 3 • 2 years.
This was not a clinical intervention. Adverse events were simply related to participating in a study.
|
0.73%
1/137 • Number of events 1 • 2 years.
This was not a clinical intervention. Adverse events were simply related to participating in a study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place