Trial Outcomes & Findings for A Comparison of Serum and Urine N-telopeptide Marker (NCT NCT05326815)
NCT ID: NCT05326815
Last Updated: 2024-09-24
Results Overview
Correlation between NTX measures with each other
Recruitment status
COMPLETED
Target enrollment
54 participants
Primary outcome timeframe
1 day (single visit lab test)
Results posted on
2024-09-24
Participant Flow
Recruitment start date- June 2022 Recruitment end date- April 2023
No randomization was involved with this study.
Participant milestones
| Measure |
Osteopenia, no Past Medical Therapy
Patients diagnosed with osteopenia on DEXA scan who have not been on any medical therapy in the past
N-Telopeptide, Bone Marker: This is a prospective specimen collection cohort study to evaluate the correlation between serum and urine values of the bone marker of interest (N-Telopeptide), and their association with baseline DEXA scan measures and fracture risk within 6 months.
Study samples will be obtained longitudinally. One collection of both serum and urine collection will be obtained. The urine will be collected as second void of day and at the same time the blood collection is drawn.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Osteopenia, no Past Medical Therapy
Patients diagnosed with osteopenia on DEXA scan who have not been on any medical therapy in the past
N-Telopeptide, Bone Marker: This is a prospective specimen collection cohort study to evaluate the correlation between serum and urine values of the bone marker of interest (N-Telopeptide), and their association with baseline DEXA scan measures and fracture risk within 6 months.
Study samples will be obtained longitudinally. One collection of both serum and urine collection will be obtained. The urine will be collected as second void of day and at the same time the blood collection is drawn.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Did not complete required labs
|
6
|
|
Overall Study
Screen fail- abnormal labs
|
5
|
Baseline Characteristics
A Comparison of Serum and Urine N-telopeptide Marker
Baseline characteristics by cohort
| Measure |
Osteopenia, no Past Medical Therapy
n=40 Participants
Patients diagnosed with osteopenia on DEXA scan who have not been on any medical therapy in the past
N-Telopeptide, Bone Marker: This is a prospective specimen collection cohort study to evaluate the correlation between serum and urine values of the bone marker of interest (N-Telopeptide), and their association with baseline DEXA scan measures and fracture risk within 6 months.
Study samples will be obtained longitudinally. One collection of both serum and urine collection will be obtained. The urine will be collected as second void of day and at the same time the blood collection is drawn.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day (single visit lab test)Correlation between NTX measures with each other
Outcome measures
| Measure |
Osteopenia, no Past Medical Therapy
n=40 Participants
Patients diagnosed with osteopenia on DEXA scan who have not been on any medical therapy in the past
N-Telopeptide, Bone Marker: This is a prospective specimen collection cohort study to evaluate the correlation between serum and urine values of the bone marker of interest (N-Telopeptide), and their association with baseline DEXA scan measures and fracture risk within 6 months.
Study samples will be obtained longitudinally. One collection of both serum and urine collection will be obtained. The urine will be collected as second void of day and at the same time the blood collection is drawn.
|
|---|---|
|
Correlation Between NTX Measures With Each Other
|
0.52 r-value
Interval 0.25 to 0.72
|
Adverse Events
Osteopenia, no Past Medical Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place