Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease

Sarcopenia, Fall and Osteoporosis in Patients With Chronic Kidney Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Sarcopenia; Osteoporosis
• Intervention / Treatment: Diagnostic test: DXA; Other: Muscle strength and function assessment; Other: Blood samples

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 Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Sabina C Hauge, MD; Phone Number: +45 28965887; Email: sabina.chaudhary.hauge@regionh.dk
• Study Contact Backup: Name: Ditte Hansen, MD, PhD; Phone Number: +45 38682056; Email: ditte.hansen.04@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev and Gentofte Hospital, Herlev Hospital
    • Contact: Sabina C Hauge; Phone Number: +4528965887; Email: sabina.chaudhary.hauge@regionh.dk
    • Contact: Ditte Hansen; Phone Number: +4538682056; Email: ditte.hansen.04@regionh.dk
    • Principal Investigator: Ditte Hansen, MD, PhD
    • Sub-Investigator: Sabina C Hauge, MD
    • Sub-Investigator: Anahita Rashid
    • Sub-Investigator: Charlotte Suetta, MD,PhD,prof.
  • Odense, Denmark, 5000
    • Not yet recruiting
    • Odense University Hospital
    • Contact: Morten F Nielsen, MD, PhD; Phone Number: +4522877448; Email: mmfnielsen@health.sdu.dk
    • Contact: Subagini Nagarajah, MD; Phone Number: +4528598621; Email: subagininagarajah3@rsyd.dk
    • Principal Investigator: Morten F Nielsen, MD,PhD
    • Sub-Investigator: Subagini Nagarajah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The patients will be recruited from the Department of Nephrology at both Herlev Hospital and Odense University Hospital during their regular visits to these outpatient clinics.

All subjects connected to the participating centers are screened to see if they are eligible for the study. Participants with a minimum age of 20 with eGFR ≤30 ml/min are asked if they wish to be examined further to see if they meet all the inclusion criteria and none of the exclusion criteria. Only participants meeting all the inclusion criteria and none of the exclusion criteria will be considered eligible for the trial.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants; 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; Each participant will undergo one DXA scan; Other: Muscle strength and function assessment; 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).; Other: Blood samples; Each patient will undergo a physical examination and also deliver blood samples.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Collaborators: Odense University Hospital
• Investigators: Principal Investigator: Ditte Hansen, MD, PhD, Department of Nephrology, Herlev and Gentofte Hospital

Publications and helpful links

General Publications

• Suetta C, Haddock B, Alcazar J, Noerst T, Hansen OM, Ludvig H, Kamper RS, Schnohr P, Prescott E, Andersen LL, Frandsen U, Aagaard P, Bulow J, Hovind P, Simonsen L. The Copenhagen Sarcopenia Study: lean mass, strength, power, and physical function in a Danish cohort aged 20-93 years. J Cachexia Sarcopenia Muscle. 2019 Dec;10(6):1316-1329. doi: 10.1002/jcsm.12477. Epub 2019 Aug 16.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Fall; Chronic kidney disease-mineral and bone disorder (CKD-MBD)
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Disease Attributes; Renal Insufficiency; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Bone Diseases; Muscular Atrophy; Atrophy; Bone Diseases, Metabolic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Sarcopenia; Osteoporosis
• Other Study ID Numbers: SarcoCKD2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For now no Individual Participant Data (IPD) are planned to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No