Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease

Recruiting

• Conditions: Sarcopenia; Osteoporosis; Chronic Kidney Diseases
• Interventions: Diagnostic Test: DXA; Other: Muscle strength and function assessment; Other: Blood samples

• Registration Number: NCT04515342
• Lead Sponsor: Herlev Hospital

Brief Summary

This study is a cross-sectional study that wishes to investigate whether there is an increased incidence of sarcopenia in patients with chronic kidney disease compared to the Danish background population. A possible association between sarcopenia and fall, as well as the incidence of osteoporosis in patients with chronic kidney disease will also be described.

Detailed Description

Sarcopenia is a condition diagnosed from different clinical findings such as low muscle mass, low muscle strength and possibly also poor physical performance. In the general population, the risk of fall and bone fracture increases, when sarcopenia is also present.

Sarcopenia is known to occur in patients with chronic kidney disease, but whether, and if so, how this differs from the incidence in patients without kidney disease has not previously been described.

Patients with chronic kidney disease have a 3 times higher risk of bone fracture compared to the Danish background population, and they also have an increased risk of falls.

The association between sarcopenia, risk of falls and osteoporosis in patients with kidney disease is until now sparsely described, and because of this, the investigators want to explore this further in this cross-sectional study.

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-17
• Study Start: 2021-03-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Age ≥20 years
• Chronic kidney disease stage 4-5 not on dialysis (nonD) (corresponding to an estimated glomerular filtration rate (eGFR) ≤30 ml/min based on Kidney Disease Improving Global Outcomes (KDIGO) definition and not on dialysis)

Exclusion Criteria

• Kidney transplanted
• Immobilized/hospitalized for more than 1 week within the last 6 weeks
• Active treatment with growth hormone or sex hormone
• Known muscle disease
• The lack of ability to speak or understand Danish
• The lack of ability to give an informed consent
• The lack of ability to participate in a clinical study based on the assessment by the local investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	DXA	This is a cross-sectional study involving approximately 150 patients. They undergo a physical examination, fill out a questionnaire, have blood samples drawn, undergo a Dual Energy X-ray Absorptiometry (DXA) scan and different physical procedures to assess muscle strength and muscle function.
Participants	Muscle strength and function assessment	This is a cross-sectional study involving approximately 150 patients. They undergo a physical examination, fill out a questionnaire, have blood samples drawn, undergo a Dual Energy X-ray Absorptiometry (DXA) scan and different physical procedures to assess muscle strength and muscle function.
Participants	Blood samples	This is a cross-sectional study involving approximately 150 patients. They undergo a physical examination, fill out a questionnaire, have blood samples drawn, undergo a Dual Energy X-ray Absorptiometry (DXA) scan and different physical procedures to assess muscle strength and muscle function.

Primary Outcome Measures

Name	Time	Method
Difference in appendicular lean body mass	Day 0 (day of study procedure)	Difference in appendicular lean body mass between patients with chronic kidney disease and a healthy control group examined in a previous study

Secondary Outcome Measures

Name	Time	Method
Difference in the incidence of sarcopenia	Day 0 (day of study procedure)	Difference in the incidence of sarcopenia between patients with chronic kidney disease and a healthy control group examined in a previous study
Difference in appendicular muscle mass	Day 0 (day of study procedure)	Difference in appendicular muscle mass between patients with chronic kidney disease and a healthy control group examined in a previous study
Difference in handgrip strength	Day 0 (day of study procedure)	Difference in handgrip strength between patients with chronic kidney disease and a healthy control group examined in a previous study
Difference in the incidence of osteoporosis	Day 0 (day of study procedure)	Difference in the incidence of osteoporoses between patients with chronic kidney disease and a healthy control group examined in a previous study
Difference in gait speed	Day 0 (day of study procedure)	Difference in gait speed between patients with chronic kidney disease and a healthy control group examined in a previous study
The correlation between total lean and appendicular lean body mass, handgrip strength, gait speed, sit-to-stand test, tendency to fall and osteoporosis	Day 0 (day of study procedure)	The correlation between total lean and appendicular lean body mass, handgrip strength, gait speed, sit-to-stand test, tendency to fall and osteoporosis (T-score \<-2.5 in hip and/or lumbal spine)
Difference in sit-to-stand test	Day 0 (day of study procedure)	Difference in sit-to-stand test between patients with chronic kidney disease and a healthy control group examined in a previous study
Difference in the tendency to fall	Day 0 (day of study procedure)	Difference in the tendency to fall between patients with chronic kidney disease and a healthy control group examined in a previous study

Trial Locations

Locations (2)

Herlev and Gentofte Hospital, Herlev Hospital; 🇩🇰 Herlev, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark