A Comparison of Serum and Urine N-telopeptide Marker

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fractures, Bone; Osteoporosis
• Intervention / Treatment: Diagnostic test: N-Telopeptide, Bone Marker

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

• Study Contact: Name: Kimberly Jenkins, MS; Phone Number: 216 312 9455; Email: jenkink@ccf.org
• Study Contact Backup: Name: Lea El Hage, MD; Phone Number: 216 444-6571; Email: ELHAGEL@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Osteopenia, no past medical therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between serum and urine N-Telopeptide markers and their association with fracture risk	Looking at N-Telopeptide levels as a predictor of increased bone fractures	6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Lea El Hage, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): March 15, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Fractures, Bone; Osteoporosis
• Other Study ID Numbers: 22-190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No