Status:

COMPLETED

A Comparison of Serum and Urine N-telopeptide Marker

Lead Sponsor:

The Cleveland Clinic

Conditions:

Osteoporosis

Fractures, Bone

Eligibility:

All Genders

18-85 years

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...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 23 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 27 2023

Estimated Enrollment :

54 Patients enrolled

Trial Details

Trial ID

NCT05326815

Start Date

June 23 2022

End Date

October 27 2023

Last Update

September 24 2024

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Cleveland Clinic

Cleveland, Ohio, United States, 44195