Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sarcopenia, Fall and Osteoporosis in Patients With Chronic Kidney Disease

Conditions
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Sarcopenia, Chronic Kidney Diseases, Osteoporosis

Intervention / Treatment
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* Diagnostic Test: DXA
* Other: Muscle strength and function assessment
* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>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. | Diagnostic Test: DXA<br>* Each participant will undergo one DXA scan<br>Other: Muscle strength and function assessment<br>* Each patient will have their muscle strength and function assessed with the measurements of handgrip strength, 10 m gait speed and a 30 s sit-to-stand test. They will also fill out a questionnaire assessing Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F questionnaire).<br>Other: Blood samples<br>* Each patient will undergo a physical examination and also deliver blood samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in appendicular lean body mass | Difference in appendicular lean body mass between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the incidence of sarcopenia | Difference in the incidence of sarcopenia between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) | 
| Difference in appendicular muscle mass | Difference in appendicular muscle mass between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) | 
| Difference in handgrip strength | Difference in handgrip strength between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) | 
| Difference in gait speed | Difference in gait speed between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) | 
| Difference in sit-to-stand test | Difference in sit-to-stand test between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) | 
| Difference in the incidence of osteoporosis | Difference in the incidence of osteoporoses between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) | 
| Difference in the tendency to fall | Difference in the tendency to fall between patients with chronic kidney disease and a healthy control group examined in a previous study | 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 | 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) | Day 0 (day of study procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fall, Chronic kidney disease-mineral and bone disorder (CKD-MBD)