Trial Outcomes & Findings for A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model (NCT NCT04135196)
NCT ID: NCT04135196
Last Updated: 2023-10-18
Results Overview
12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
baseline and 12 months
Results posted on
2023-10-18
Participant Flow
Recruitment Period: December 2013-June 2017 All participants were recruited at a single site (Worcester Polytechnic Institute) and the surrounding community via social media, posters, email newsletters, and word of mouth at nearby universities, hospitals, and community events.
Participant milestones
| Measure |
Low Magnitude
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
observation only
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
24
|
21
|
20
|
16
|
|
Overall Study
COMPLETED
|
13
|
17
|
12
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
9
|
9
|
2
|
Reasons for withdrawal
| Measure |
Low Magnitude
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
observation only
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
7
|
8
|
9
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
Baseline characteristics by cohort
| Measure |
Low Magnitude
n=21 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=24 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=21 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=20 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=16 Participants
observation only
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 5.5 • n=21 Participants
|
29.3 years
STANDARD_DEVIATION 6.3 • n=24 Participants
|
27.2 years
STANDARD_DEVIATION 5.1 • n=21 Participants
|
27.1 years
STANDARD_DEVIATION 5.4 • n=20 Participants
|
28.2 years
STANDARD_DEVIATION 5.3 • n=16 Participants
|
28.4 years
STANDARD_DEVIATION 5.6 • n=102 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=21 Participants
|
24 Participants
n=24 Participants
|
21 Participants
n=21 Participants
|
20 Participants
n=20 Participants
|
16 Participants
n=16 Participants
|
102 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=21 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=21 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=16 Participants
|
12 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=21 Participants
|
18 Participants
n=24 Participants
|
20 Participants
n=21 Participants
|
18 Participants
n=20 Participants
|
14 Participants
n=16 Participants
|
89 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=102 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=21 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=16 Participants
|
12 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=21 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=102 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=21 Participants
|
17 Participants
n=24 Participants
|
16 Participants
n=21 Participants
|
14 Participants
n=20 Participants
|
13 Participants
n=16 Participants
|
76 Participants
n=102 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=21 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=16 Participants
|
7 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=21 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=16 Participants
|
5 Participants
n=102 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
24 participants
n=24 Participants
|
21 participants
n=21 Participants
|
20 participants
n=20 Participants
|
16 participants
n=16 Participants
|
102 participants
n=102 Participants
|
|
Height
|
165.8 cm
STANDARD_DEVIATION 6.1 • n=21 Participants
|
161.9 cm
STANDARD_DEVIATION 6.1 • n=24 Participants
|
165.0 cm
STANDARD_DEVIATION 6.2 • n=21 Participants
|
164.9 cm
STANDARD_DEVIATION 5.7 • n=20 Participants
|
167.3 cm
STANDARD_DEVIATION 7.6 • n=16 Participants
|
164.8 cm
STANDARD_DEVIATION 6.4 • n=102 Participants
|
|
Body Mass
|
65.2 kg
STANDARD_DEVIATION 8.8 • n=21 Participants
|
61.0 kg
STANDARD_DEVIATION 5.9 • n=24 Participants
|
65.4 kg
STANDARD_DEVIATION 9.8 • n=21 Participants
|
65.4 kg
STANDARD_DEVIATION 10 • n=20 Participants
|
65.0 kg
STANDARD_DEVIATION 8.9 • n=16 Participants
|
64.3 kg
STANDARD_DEVIATION 8.7 • n=102 Participants
|
|
Serum Vitamin D
|
33.7 ng/mL
STANDARD_DEVIATION 9.9 • n=21 Participants
|
31.5 ng/mL
STANDARD_DEVIATION 8.9 • n=24 Participants
|
31.1 ng/mL
STANDARD_DEVIATION 12.2 • n=21 Participants
|
29.1 ng/mL
STANDARD_DEVIATION 7.8 • n=20 Participants
|
33.2 ng/mL
STANDARD_DEVIATION 7.5 • n=16 Participants
|
31.7 ng/mL
STANDARD_DEVIATION 9.5 • n=102 Participants
|
|
Total Forearm aBMD
|
0.586 g/cm^2
STANDARD_DEVIATION 0.04 • n=21 Participants
|
0.568 g/cm^2
STANDARD_DEVIATION 0.03 • n=24 Participants
|
0.576 g/cm^2
STANDARD_DEVIATION 0.04 • n=21 Participants
|
0.569 g/cm^2
STANDARD_DEVIATION 0.04 • n=20 Participants
|
0.570 g/cm^2
STANDARD_DEVIATION 0.04 • n=16 Participants
|
0.574 g/cm^2
STANDARD_DEVIATION 0.04 • n=102 Participants
|
|
DXA Total Forearm T-score
|
0.138 t-score
STANDARD_DEVIATION 0.76 • n=21 Participants
|
-0.187 t-score
STANDARD_DEVIATION 0.63 • n=24 Participants
|
0.138 t-score
STANDARD_DEVIATION 0.76 • n=21 Participants
|
-0.175 t-score
STANDARD_DEVIATION 0.74 • n=20 Participants
|
-0.162 t-score
STANDARD_DEVIATION 0.67 • n=16 Participants
|
-0.087 t-score
STANDARD_DEVIATION 0.70 • n=102 Participants
|
|
Ultradistal iBMC
All Enrolled Participants
|
0.940 g
STANDARD_DEVIATION 0.179 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.886 g
STANDARD_DEVIATION 0.149 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.894 g
STANDARD_DEVIATION 0.141 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.844 g
STANDARD_DEVIATION 0.155 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.883 g
STANDARD_DEVIATION 0.116 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.890 g
STANDARD_DEVIATION 0.151 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal iBMC
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
0.997 g
STANDARD_DEVIATION 0.143 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.849 g
STANDARD_DEVIATION 0.134 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.926 g
STANDARD_DEVIATION 0.160 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.875 g
STANDARD_DEVIATION 0.140 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.898 g
STANDARD_DEVIATION 0.124 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.906 g
STANDARD_DEVIATION 0.145 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for the group of participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal cBMC
All Enrolled Participants
|
0.432 g
STANDARD_DEVIATION 0.163 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.380 g
STANDARD_DEVIATION 0.123 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.369 g
STANDARD_DEVIATION 0.109 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.354 g
STANDARD_DEVIATION 0.104 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.356 g
STANDARD_DEVIATION 0.077 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.380 g
STANDARD_DEVIATION 0.122 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal cBMC
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
0.457 g
STANDARD_DEVIATION 0.177 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.351 g
STANDARD_DEVIATION 0.117 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.377 g
STANDARD_DEVIATION 0.132 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.369 g
STANDARD_DEVIATION 0.104 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.369 g
STANDARD_DEVIATION 0.076 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.383 g
STANDARD_DEVIATION 0.128 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal ecBMC
All Enrolled Participants
|
0.692 g
STANDARD_DEVIATION 0.226 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.607 g
STANDARD_DEVIATION 0.181 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.617 g
STANDARD_DEVIATION 0.163 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.564 g
STANDARD_DEVIATION 0.171 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.597 g
STANDARD_DEVIATION 0.127 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.617 g
STANDARD_DEVIATION 0.180 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal ecBMC
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
0.745 g
STANDARD_DEVIATION 0.211 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.556 g
STANDARD_DEVIATION 0.149 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.644 g
STANDARD_DEVIATION 0.195 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.596 g
STANDARD_DEVIATION 0.172 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.613 g
STANDARD_DEVIATION 0.135 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.627 g
STANDARD_DEVIATION 0.180 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal tBMC
All Enrolled Participants
|
0.182 g
STANDARD_DEVIATION 0.061 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.177 g
STANDARD_DEVIATION 0.053 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.181 g
STANDARD_DEVIATION 0.053 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.158 g
STANDARD_DEVIATION 0.061 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.179 g
STANDARD_DEVIATION 0.052 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.175 g
STANDARD_DEVIATION 0.056 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal tBMC
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
0.201 g
STANDARD_DEVIATION 0.039 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.166 g
STANDARD_DEVIATION 0.048 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.196 g
STANDARD_DEVIATION 0.062 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.170 g
STANDARD_DEVIATION 0.047 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.184 g
STANDARD_DEVIATION 0.057 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.182 g
STANDARD_DEVIATION 0.051 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal iBV
All Enrolled Participants
|
3.88 cm^3
STANDARD_DEVIATION 0.44 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.73 cm^3
STANDARD_DEVIATION 0.34 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.78 cm^3
STANDARD_DEVIATION 0.45 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.72 cm^3
STANDARD_DEVIATION 0.53 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.79 cm^3
STANDARD_DEVIATION 0.37 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.78 cm^3
STANDARD_DEVIATION 0.43 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal iBV
Subset of Participants who were also Analyzed at Follow-up (12 months)
|
4.02 cm^3
STANDARD_DEVIATION 0.39 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.70 cm^3
STANDARD_DEVIATION 0.34 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.88 cm^3
STANDARD_DEVIATION 0.38 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.77 cm^3
STANDARD_DEVIATION 0.56 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.85 cm^3
STANDARD_DEVIATION 0.28 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
3.84 cm^3
STANDARD_DEVIATION 0.40 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal cBV
All Enrolled Participants
|
0.88 cm^3
STANDARD_DEVIATION 0.26 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.80 cm^3
STANDARD_DEVIATION 0.22 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.79 cm^3
STANDARD_DEVIATION 0.20 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.74 cm^3
STANDARD_DEVIATION 0.20 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.76 cm^3
STANDARD_DEVIATION 0.15 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.79 cm^3
STANDARD_DEVIATION 0.21 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal cBV
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
0.92 cm^3
STANDARD_DEVIATION 0.26 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.74 cm^3
STANDARD_DEVIATION 0.20 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.81 cm^3
STANDARD_DEVIATION 0.25 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.78 cm^3
STANDARD_DEVIATION 0.21 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.78 cm^3
STANDARD_DEVIATION 0.14 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.80 cm^3
STANDARD_DEVIATION 0.22 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal ecBV
All Enrolled Participants
|
2.02 cm^3
STANDARD_DEVIATION 0.15 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.96 cm^3
STANDARD_DEVIATION 0.14 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.98 cm^3
STANDARD_DEVIATION 0.18 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.93 cm^3
STANDARD_DEVIATION 0.19 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.96 cm^3
STANDARD_DEVIATION 0.11 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.97 cm^3
STANDARD_DEVIATION 0.16 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal ecBV
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
2.08 cm^3
STANDARD_DEVIATION 0.12 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.93 cm^3
STANDARD_DEVIATION 0.12 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
2.02 cm^3
STANDARD_DEVIATION 0.15 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.96 cm^3
STANDARD_DEVIATION 0.21 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.98 cm^3
STANDARD_DEVIATION 0.09 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.99 cm^3
STANDARD_DEVIATION 0.15 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal tBV
All Enrolled Participants
|
1.47 cm^3
STANDARD_DEVIATION 0.30 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.39 cm^3
STANDARD_DEVIATION 0.23 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.41 cm^3
STANDARD_DEVIATION 0.26 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.38 cm^3
STANDARD_DEVIATION 0.31 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.42 cm^3
STANDARD_DEVIATION 0.27 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.41 cm^3
STANDARD_DEVIATION 0.27 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal tBV
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
1.55 cm^3
STANDARD_DEVIATION 0.30 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.38 cm^3
STANDARD_DEVIATION 0.24 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.45 cm^3
STANDARD_DEVIATION 0.24 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.42 cm^3
STANDARD_DEVIATION 0.32 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.46 cm^3
STANDARD_DEVIATION 0.22 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
1.45 cm^3
STANDARD_DEVIATION 0.26 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal iBMD
All Enrolled Participants
|
0.243 g/cm^3
STANDARD_DEVIATION 0.044 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.238 g/cm^3
STANDARD_DEVIATION 0.035 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.237 g/cm^3
STANDARD_DEVIATION 0.030 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.228 g/cm^3
STANDARD_DEVIATION 0.033 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.234 g/cm^3
STANDARD_DEVIATION 0.031 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.236 g/cm^3
STANDARD_DEVIATION 0.035 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal iBMD
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
0.250 g/cm^3
STANDARD_DEVIATION 0.044 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.230 g/cm^3
STANDARD_DEVIATION 0.033 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.239 g/cm^3
STANDARD_DEVIATION 0.032 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.233 g/cm^3
STANDARD_DEVIATION 0.029 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.233 g/cm^3
STANDARD_DEVIATION 0.029 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.237 g/cm^3
STANDARD_DEVIATION 0.034 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal cBMD
All Enrolled Participants
|
0.486 g/cm^3
STANDARD_DEVIATION 0.035 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.471 g/cm^3
STANDARD_DEVIATION 0.029 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.465 g/cm^3
STANDARD_DEVIATION 0.028 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.473 g/cm^3
STANDARD_DEVIATION 0.027 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.468 g/cm^3
STANDARD_DEVIATION 0.014 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.473 g/cm^3
STANDARD_DEVIATION 0.028 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal cBMD
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
0.485 g/cm^3
STANDARD_DEVIATION 0.039 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.469 g/cm^3
STANDARD_DEVIATION 0.033 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.462 g/cm^3
STANDARD_DEVIATION 0.029 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.470 g/cm^3
STANDARD_DEVIATION 0.023 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.471 g/cm^3
STANDARD_DEVIATION 0.013 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.471 g/cm^3
STANDARD_DEVIATION 0.029 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal ecBMD
All Enrolled Participants
|
0.339 g/cm^3
STANDARD_DEVIATION 0.097 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.307 g/cm^3
STANDARD_DEVIATION 0.075 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.310 g/cm^3
STANDARD_DEVIATION 0.067 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.289 g/cm^3
STANDARD_DEVIATION 0.075 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.305 g/cm^3
STANDARD_DEVIATION 0.059 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.310 g/cm^3
STANDARD_DEVIATION 0.077 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal ecBMD
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
0.358 g/cm^3
STANDARD_DEVIATION 0.092 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.286 g/cm^3
STANDARD_DEVIATION 0.064 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.315 g/cm^3
STANDARD_DEVIATION 0.080 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.301 g/cm^3
STANDARD_DEVIATION 0.069 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.309 g/cm^3
STANDARD_DEVIATION 0.063 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.312 g/cm^3
STANDARD_DEVIATION 0.076 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal tBMD
All Enrolled Participants
|
0.122 g/cm^3
STANDARD_DEVIATION 0.033 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.128 g/cm^3
STANDARD_DEVIATION 0.031 • n=24 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.129 g/cm^3
STANDARD_DEVIATION 0.024 • n=21 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.112 g/cm^3
STANDARD_DEVIATION 0.031 • n=20 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.127 g/cm^3
STANDARD_DEVIATION 0.035 • n=16 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.124 g/cm^3
STANDARD_DEVIATION 0.031 • n=102 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Ultradistal tBMD
Subset of Participants who were also Analyzed at Follow-Up (12 months)
|
0.131 g/cm^3
STANDARD_DEVIATION 0.022 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.121 g/cm^3
STANDARD_DEVIATION 0.028 • n=17 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.133 g/cm^3
STANDARD_DEVIATION 0.027 • n=12 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.120 g/cm^3
STANDARD_DEVIATION 0.026 • n=11 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.125 g/cm^3
STANDARD_DEVIATION 0.033 • n=13 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
0.126 g/cm^3
STANDARD_DEVIATION 0.027 • n=66 Participants • All Enrolled Participants includes the 102 participants randomized into study arms. The Subset of Participants who were also Analyzed at Follow-up row reports baseline values for participants with 12 month follow-up data available, for more direct comparison with reported group changes.
|
|
Trabecular BV/TV
|
0.131 ratio
STANDARD_DEVIATION 0.024 • n=18 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4).
|
0.135 ratio
STANDARD_DEVIATION 0.026 • n=23 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4).
|
0.138 ratio
STANDARD_DEVIATION 0.026 • n=21 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4).
|
0.130 ratio
STANDARD_DEVIATION 0.024 • n=20 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4).
|
0.141 ratio
STANDARD_DEVIATION 0.030 • n=15 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4).
|
0.135 ratio
STANDARD_DEVIATION 0.026 • n=97 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4).
|
|
Cortical Thickness
|
0.811 mm
STANDARD_DEVIATION 0.168 • n=18 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4 according to Pialat et al. (2012) Bone).
|
0.753 mm
STANDARD_DEVIATION 0.162 • n=23 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4 according to Pialat et al. (2012) Bone).
|
0.795 mm
STANDARD_DEVIATION 0.154 • n=21 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4 according to Pialat et al. (2012) Bone).
|
0.828 mm
STANDARD_DEVIATION 0.110 • n=20 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4 according to Pialat et al. (2012) Bone).
|
0.724 mm
STANDARD_DEVIATION 0.085 • n=15 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4 according to Pialat et al. (2012) Bone).
|
0.784 mm
STANDARD_DEVIATION 0.144 • n=97 Participants • Analysis population includes individuals with high quality baseline HRpQCT scans (motion artifact score \<4 according to Pialat et al. (2012) Bone).
|
PRIMARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD iBMC
|
0.0049 g
Standard Deviation 0.0146
|
-0.0020 g
Standard Deviation 0.0165
|
0.0252 g
Standard Deviation 0.0206
|
0.0309 g
Standard Deviation 0.0211
|
-0.0106 g
Standard Deviation 0.0241
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD cBMC
|
0.0037 g
Standard Deviation 0.0127
|
-0.0001 g
Standard Deviation 0.0101
|
0.0139 g
Standard Deviation 0.0124
|
0.0166 g
Standard Deviation 0.0176
|
0.0024 g
Standard Deviation 0.0243
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD ecBMC
|
0.0007 g
Standard Deviation 0.0173
|
0.0001 g
Standard Deviation 0.0151
|
0.0286 g
Standard Deviation 0.0240
|
0.0287 g
Standard Deviation 0.0274
|
-0.0004 g
Standard Deviation 0.0311
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD tBMC
|
0.0018 g
Standard Deviation 0.0082
|
-0.0021 g
Standard Deviation 0.0067
|
0.0072 g
Standard Deviation 0.0092
|
0.0112 g
Standard Deviation 0.0106
|
-0.0048 g
Standard Deviation 0.0107
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal integral volumetric bone mineral density, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD iBMD
|
-0.0008 g/cm^3
Standard Deviation 0.0024
|
-0.0007 g/cm^3
Standard Deviation 0.0027
|
0.0072 g/cm^3
Standard Deviation 0.0027
|
0.0071 g/cm^3
Standard Deviation 0.0035
|
-0.0014 g/cm^3
Standard Deviation 0.0047
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal cortical volumetric bone mineral density, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD cBMD
|
-0.0025 g/cm^3
Standard Deviation 0.0068
|
-0.0015 g/cm^3
Standard Deviation 0.0073
|
0.0073 g/cm^3
Standard Deviation 0.0058
|
0.0036 g/cm^3
Standard Deviation 0.0081
|
0.0029 g/cm^3
Standard Deviation 0.0101
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal endocortical bone mineral density, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD ecBMD
|
-0.0031 g/cm^3
Standard Deviation 0.0102
|
-0.0012 g/cm^3
Standard Deviation 0.0080
|
0.0141 g/cm^3
Standard Deviation 0.0105
|
0.0122 g/cm^3
Standard Deviation 0.0116
|
0.0005 g/cm^3
Standard Deviation 0.0141
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal trabecular bone mineral density, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD tBMD
|
0.0006 g/cm^3
Standard Deviation 0.0028
|
-0.0013 g/cm^3
Standard Deviation 0.0036
|
0.0050 g/cm^3
Standard Deviation 0.0043
|
0.0071 g/cm^3
Standard Deviation 0.0053
|
-0.0029 g/cm^3
Standard Deviation 0.0046
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal integral bone volume, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD iBV
|
0.027 cm^3
Standard Deviation 0.061
|
0.003 cm^3
Standard Deviation 0.055
|
-0.011 cm^3
Standard Deviation 0.049
|
0.012 cm^3
Standard Deviation 0.066
|
-0.026 cm^3
Standard Deviation 0.068
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD cBV
|
0.014 cm^3
Standard Deviation 0.028
|
0.003 cm^3
Standard Deviation 0.028
|
0.016 cm^3
Standard Deviation 0.035
|
0.031 cm^3
Standard Deviation 0.038
|
0.002 cm^3
Standard Deviation 0.056
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD ecBV
|
0.018 cm^3
Standard Deviation 0.029
|
0.008 cm^3
Standard Deviation 0.030
|
-0.0003 cm^3
Standard Deviation 0.025
|
0.009 cm^3
Standard Deviation 0.028
|
-0.007 cm^3
Standard Deviation 0.030
|
SECONDARY outcome
Timeframe: baseline and 12 months12-month change in ultra-distal trabecular bone volume, measured with quantitative computed tomography (QCT)
Outcome measures
| Measure |
Low Magnitude
n=13 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=17 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=12 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=13 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in UD tBV
|
0.006 cm^3
Standard Deviation 0.029
|
-0.004 cm^3
Standard Deviation 0.023
|
-0.003 cm^3
Standard Deviation 0.023
|
0.006 cm^3
Standard Deviation 0.034
|
-0.011 cm^3
Standard Deviation 0.033
|
SECONDARY outcome
Timeframe: measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollmentPopulation: Analysis population includes participants analyzed at at least one interim timepoint. Exact values are provided for individual timepoints below.
Changes in cortical thickness at 3-month intervals, measured with high resolution peripheral quantitative computed tomography (HRpQCT)
Outcome measures
| Measure |
Low Magnitude
n=15 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=21 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=15 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=15 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in Cortical Thickness
3 months
|
0.001 mm
Standard Deviation 0.018
|
-0.012 mm
Standard Deviation 0.056
|
0.009 mm
Standard Deviation 0.030
|
0.032 mm
Standard Deviation 0.031
|
-0.004 mm
Standard Deviation 0.018
|
|
Change in Cortical Thickness
6 months
|
-0.003 mm
Standard Deviation 0.037
|
0.002 mm
Standard Deviation 0.021
|
0.008 mm
Standard Deviation 0.025
|
0.005 mm
Standard Deviation 0.025
|
0.004 mm
Standard Deviation 0.018
|
|
Change in Cortical Thickness
9 months
|
0.001 mm
Standard Deviation 0.015
|
-0.012 mm
Standard Deviation 0.064
|
0.006 mm
Standard Deviation 0.019
|
-0.007 mm
Standard Deviation 0.022
|
-0.002 mm
Standard Deviation 0.021
|
|
Change in Cortical Thickness
12 months
|
-0.009 mm
Standard Deviation 0.027
|
-0.002 mm
Standard Deviation 0.027
|
0.015 mm
Standard Deviation 0.018
|
0.004 mm
Standard Deviation 0.029
|
0.002 mm
Standard Deviation 0.022
|
SECONDARY outcome
Timeframe: measurements repeated at 0, 3, 6, 9, and 12 months from enrollmentPopulation: Analysis population includes participants analyzed at at least one interim timepoint. Exact values are provided for individual timepoints below.
trabecular bone volume fraction expressed as the ratio of bone volume (BV) to total volume (TV) using: (BV/TV). This quantity is measured with high resolution peripheral quantitative computed tomography (HRpQCT). It is expressed as a ratio, ranging from 0 (none of the volume is occupied by bone) to 1 (all of the volume is occupied by bone).
Outcome measures
| Measure |
Low Magnitude
n=15 Participants
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=21 Participants
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=15 Participants
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=11 Participants
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=15 Participants
observation only
|
|---|---|---|---|---|---|
|
Change in Trabecular BV/TV
6 months
|
0.0006 ratio
Standard Deviation 0.0030
|
-0.0004 ratio
Standard Deviation 0.0031
|
0.0011 ratio
Standard Deviation 0.0027
|
0.0008 ratio
Standard Deviation 0.0030
|
-0.0007 ratio
Standard Deviation 0.0032
|
|
Change in Trabecular BV/TV
9 months
|
0.0014 ratio
Standard Deviation 0.0020
|
-0.0004 ratio
Standard Deviation 0.0027
|
0.0003 ratio
Standard Deviation 0.0030
|
-0.0001 ratio
Standard Deviation 0.0034
|
-0.0020 ratio
Standard Deviation 0.0028
|
|
Change in Trabecular BV/TV
12 months
|
0.0002 ratio
Standard Deviation 0.0026
|
0.0010 ratio
Standard Deviation 0.0033
|
0.0009 ratio
Standard Deviation 0.0032
|
0.0007 ratio
Standard Deviation 0.0034
|
0.000 ratio
Standard Deviation 0.0048
|
|
Change in Trabecular BV/TV
3 months
|
-0.0006 ratio
Standard Deviation 0.0023
|
0.0003 ratio
Standard Deviation 0.0030
|
-0.0020 ratio
Standard Deviation 0.0044
|
0.0002 ratio
Standard Deviation 0.0025
|
-0.0014 ratio
Standard Deviation 0.0021
|
Adverse Events
Low Magnitude
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
High Magnitude
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Low Rate
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
High Rate
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Magnitude
n=21 participants at risk
voluntary forearm compression by leaning onto the palm of the hand with low target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Magnitude
n=24 participants at risk
voluntary forearm compression by leaning onto the palm of the hand with high target strain
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Low Rate
n=21 participants at risk
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
High Rate
n=20 participants at risk
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
voluntary forearm loading task: voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
|
Control
n=16 participants at risk
observation only
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Temporary Wrist Soreness
|
38.1%
8/21 • Number of events 8 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
25.0%
6/24 • Number of events 6 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
38.1%
8/21 • Number of events 11 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
40.0%
8/20 • Number of events 10 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
18.8%
3/16 • Number of events 4 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
|
Musculoskeletal and connective tissue disorders
Arm Pain
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
20.8%
5/24 • Number of events 5 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
15.0%
3/20 • Number of events 5 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
|
Musculoskeletal and connective tissue disorders
Other injury or pain
|
0.00%
0/21 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
0.00%
0/21 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
0.00%
0/20 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
12.5%
2/16 • Number of events 3 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/21 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
0.00%
0/24 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
0.00%
0/20 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
0.00%
0/16 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
|
Musculoskeletal and connective tissue disorders
Wrist Bump
|
0.00%
0/21 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
0.00%
0/21 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
0.00%
0/20 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
0.00%
0/16 • Adverse event data were collected for each participant for the 2-year study period following enrollment.
At each visit, the standard Study Visit Data Collection Sheet recorded whether participants had experienced in the past 3 months: 1. Aches or pain in the non-dominant wrist 2. Fractures 3. Other problems that you think might be associated with participating in this research 4. Other problems that have prevented you from completing your assigned intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place