A Comparison of Serum and Urine N-telopeptide Marker

NCT05326815 | Completed Results

• 1 other identifier: 22-190
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Fractures, Bone

Outcome Measures

Primary Outcomes (1)

• Correlation Between NTX Measures With Each Other

  Correlation between NTX measures with each other

  1 day (single visit lab test)

Study Arms (1)

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

Interventions

N-Telopeptide, Bone Marker DIAGNOSTIC_TEST

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.

Osteopenia, no past medical therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Consent to participate in the study
• Participants limited to subjects in the CCF
• Age between and inclusive of 18 and 85 years of age
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Results Point of Contact

• Title: Kim Jenkins
• Organization: The Cleveland Clinic Foundation

jenkink@ccf.org

216-445-4791

Study Officials

• Lea El Hage, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 14, 2022
• Study Start: June 23, 2022
• Primary Completion: March 15, 2023
• Study Completion: October 27, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)