N/A
N=54
A Comparison of Serum and Urine N-telopeptide Marker
Osteoporosis · Fractures, Bone
Bottom Line
View on ClinicalTrials.gov: NCT05326815 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Correlation Between NTX Measures With Each Other — 0.52 r-value — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- N-Telopeptide, Bone Marker (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between NTX Measures With Each Other |
0.52 | <0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Consent to participate in the study
- Participants limited to subjects in the CCF
- Age between and inclusive of 18 and 85 years of age
- No gender exclusion
- 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
- Prior history of medical therapy for osteopenia
- Prior radiation therapy
- Prior history of bone fracture
- History of high risk medication associated with increased risk of fracture
- Presence of abnormal vitamin D levels, kidney function, and parathyroid hormone
- Pregnancy status (verbal)
- Those with medical co-morbidities that increase the risk of fracture will be excluded and these include but are not limited to: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, diabetes mellitus, hyperparathyroidism, chronic kidney disease, pituitary disease, multiple myeloma, leukemia, lymphoma, thalassemia major, HIV/AIDS, malabsorption, Inflammatory bowel disease, chronic obstructive pulmonary disease, hypogonadism, chronic liver disease, untreated hyperthyroidism, and those with chronic immobility
Data sourced from ClinicalTrials.gov (NCT05326815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.