An observational study in Osteoporosis and Fractures, Bone, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by The Cleveland Clinic · Observational
This is a prospective specimen collection cohort study to evaluate the correlation between serum and urine values of the bone marker of interest, 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. Study will continue for a period or 1 year, with plan to enroll around 40 subjects.
Osteoporosis is the most common metabolic disorder in the United States and it is estimated that approximately 19% of women and 4% of men over the age 50 years have underlying disease. This number is expected to continue to rise. A silent illness at first, once presenting with fractures, it can lead to increased morbidity, mortality, and decreased quality of life. It carries large financial and societal burdens. Direct annual medical costs are estimated to be approximately 17 to 20 billion dollars in the United States alone. Therefore, it is important to accurately identify those at high risk.
The present gold standard to diagnose osteoporosis is the Dual-energy X-ray absorptiometry (DEXA scan) with a diagnosis based on a T-score of -2.5 SD or below in those without history of fragility fracture. However, many individuals fracture despite having normal or only mildly reduced scores. There are also several barriers within the DEXA technology including accessibility, cost, accurate reference ranges for age and demographic groups that result in missing large groups of people at risk for osteoporosis. The Fracture Risk Assessment Tool (FRAX score) is one tool that identifies those at higher risk of fracture that may benefit from therapy. It was designed and released in 2008 and has been a great asset in clinical practice in stratifying risk and guiding management of osteopenic patients. However, FRAX may miss many individuals that may benefit from therapy due to its limited inclusion criteria.
Bone markers have been shown to predict fracture risk in postmenopausal women independent of bone mineral density and may help identify high risk individuals. Amino-terminal cross-linking telopeptides of type I collagen (NTX) reflects osteoclastic bone resorption. NTX can be measured in both the serum and in urine.
The accuracy of the serum NTX is unclear. It may be less sensitive than urine NTX in detecting bone density changes. The urine NTX overcomes circadian rhythm changes to bone density and is less sensitive to dietary collagen intake. At present, urine markers need to be checked as a second void of the day which may be cumbersome for patients. Serum levels drawn with other bone labs would be easier to obtain than second void urine collections. The study team involved with this research would like to evaluate the correlation between serum and urine NTX in patients with osteopenia with no prior history of osteoporotic treatment. If the urine and serum markers are equivalent methods, serum levels would be preferred to identify high risk patients at risk of disease due to ease of collection.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 54 is below the median of 174 across 446 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with Osteopenia on DEXA scan who have not been on any medical therapy in the past Presence of normal vitamin D levels, kidney function, and parathyroid hormone levels (per our reference ranges)
Exclusion Criteria:
Patients diagnosed with osteopenia on DEXA scan who have not been on any medical therapy in the past
Diagnostic Test: 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
Correlation between NTX measures with each other
Time frame: 1 day (single visit lab test)
Recruitment start date- June 2022 Recruitment end date- April 2023
| Milestone | Osteopenia, no Past Medical Therapy |
|---|---|
| Started | 54 |
| Completed | 40 |
| Not completed | 14 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Did not complete required labs | 6 |
| Withdrew: Screen fail- abnormal labs | 5 |
Correlation between NTX measures with each other
| r-value | Osteopenia, no Past Medical Therapy |
|---|---|
| Correlation Between NTX Measures With Each Other | 0.52 (0.25 to 0.72) |
Collected over Adverse event data was collected from June 2022 until the end of study in March 2023. Patients participating on this study during a single day lab collection.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Osteopenia, no Past Medical Therapy | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
14 patients who were enrolled did not complete baseline assessments
| Age, Categorical(Participants) | Osteopenia, no Past Medical Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 24 |
| Age, Continuous(years) | Osteopenia, no Past Medical Therapy |
|---|---|
| Mean | 66.7 ± 6.3 |
| Sex: Female, Male(Participants) | Osteopenia, no Past Medical Therapy |
|---|---|
| Female | 38 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Osteopenia, no Past Medical Therapy |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 39 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Osteopenia, no Past Medical Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 36 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Osteopenia, no Past Medical Therapy |
|---|---|
| United States | 40 |
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Plan to share: No
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