Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease

Osteoporosis Clinical Trial

Official title:

Sarcopenia, Fall and Osteoporosis in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04515342
• Other study ID #: SarcoCKD2020
• Status: Recruiting
• Start date: March 10, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: Herlev Hospital
• Contact: Sabina C Hauge, MD
• Phone: +45 28965887
• Email: sabina.chaudhary.hauge[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Gender: All
• Age group: 20 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Osteoporosis
• Renal Insufficiency, Chronic
• Sarcopenia

Intervention

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).
• Blood samples
Each patient will undergo a physical examination and also deliver blood samples.

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital, Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)