RecruitingNCT07094568

Tirzepatide vs Liraglutide in Bone

Comparative Investigation of Changes in Body Composition and Bone Turnover Markers in People With Obesity After Treatment With Tirzepatide Versus Liraglutide. A Prospective Cohort Study.

Sponsor

National and Kapodistrian University of Athens

Enrollment

72 participants

Start Date

May 23, 2025

Study Type

OBSERVATIONAL

Conditions

Obesity (Disorder)

Summary

This prospective cohort study investigates the effects of tirzepatide versus liraglutide on bone turnover markers and body composition in adults with class 3 obesity, characterised by Body Mass Index (BMI) ≥40 kg/m². Participants will be followed for 6 months with assessments at baseline, 3 and 6. The primary outcome is the change in bone resorption marker C-terminal telopeptide of type I collagen (CTX) at 3 months. Secondary outcomes include changes in body weight, BMI, bone mineral density (BMD), and body composition. The study aims to clarify the differential impact of weight loss achieved through tirzepatide versus liraglutide on bone metabolism and body composition in adults with obesity.

Eligibility

Min Age: 30 YearsMax Age: 65 Years

Inclusion Criteria2

Adults aged between 30 and 65 years
BMI ≥40 kg/m²

Exclusion Criteria14

Type 2 Diabetes Mellitus (T2DM) and type 1 Diabetes Mellitus (T1DM)
Chronic kidney disease
Liver failure
Heart failure
Malignancy coexistence
Previous bariatric or gastrointestinal surgery involving intestinal bypass
Uncontrolled hypo/hyperthyroidism
Uncontrolled hypo/hyperparathyroidism
Pregnancy and lactation
Recent fracture (within 2 years)
Rare Metabolic Bone Diseases (e.g., Paget's disease of bone, fibrous dysplasia, osteopetrosis)
Inflammatory arthritis
Medications which can affect bone markers: bone-anabolic agents, antiresorptive agents, antiandrogenic agents, vitamin K antagonists, antipsychotic agents, contraceptives, glucocorticoids (oral), methotrexate, thiazides, aromatase inhibitors etc)
Hemolytic anemia