SarcopeniaNCT04515342
Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease
An observational study of Sarcopenia and Chronic Kidney Diseases, run by Herlev Hospital at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 20 to 120 years
- Conditions the study is for
- Sarcopenia, Chronic Kidney Diseases, Osteoporosis
- What is being tested?
- DXA, Muscle strength and function assessment and Blood samples
- How many people
- 140 participants
- Where
- 2 sitesDenmark
- Study dates
- 10 Mar 2021to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 120 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Herlev and Gentofte Hospital, Herlev Hospital
Herlev, 2730
Sabina C Hauge, +4528965887, sabina.chaudhary.hauge@regionh.dk
Ditte Hansen, +4538682056, ditte.hansen.04@regionh.dk
- Not yet recruiting
Odense University Hospital
Odense, 5000
Morten F Nielsen, MD, PhD, +4522877448, mmfnielsen@health.sdu.dk
Subagini Nagarajah, MD, +4528598621, subagininagarajah3@rsyd.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia, Chronic Kidney Diseases, Osteoporosis
- Being tested
- DXA, Muscle strength and function assessment, Blood samples
- Keywords
- Fall, Chronic kidney disease-mineral and bone disorder (CKD-MBD)
- Medical subject headings
- Sarcopenia, Renal Insufficiency, Chronic, Osteoporosis, Bone Diseases, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXADiagnostic test
Each participant will undergo one DXA scan
Muscle strength and function assessmentOther
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 samplesOther
Each patient will undergo a physical examination and also deliver blood samples.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: DXA; Other: Muscle strength and function assessment; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 (day of study procedure)
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 0 (day of study procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start10 Mar 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Ditte Hansen, Herlev Hospital
- Investigators
- Ditte Hansen, MD, PhD, Principal investigator, Department of Nephrology, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515342
- Sponsor's protocol ID
- SarcoCKD2020
- Status last verified
- Apr 2024
- First submitted
- 13 Aug 2020
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For now no Individual Participant Data (IPD) are planned to be shared with other researchers.
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.
PubMed 31419087
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia, Fall and Osteoporosis in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04515342
- Acronym / sponsor ID
- SarcoCKD2020
- Conditions
- Sarcopenia, Chronic Kidney Diseases, Osteoporosis
- Keywords
- Fall, Chronic kidney disease-mineral and bone disorder (CKD-MBD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Diagnostic Test: DXA, Other: Muscle strength and function assessment, Other: Blood samplesThis 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. |
Who may qualify
- Ages
- 20 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXAEach participant will undergo one DXA scan | Diagnostic test | Participants |
| Muscle strength and function assessmentEach 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 | Participants |
| Blood samplesEach patient will undergo a physical examination and also deliver blood samples. | Other | Participants |
Primary outcome
Difference in appendicular lean body mass
Time frame: 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
8 secondary outcomes
Difference in the incidence of sarcopenia
Time frame: Day 0 (day of study procedure)
Difference in appendicular muscle mass
Time frame: Day 0 (day of study procedure)
Difference in handgrip strength
Time frame: Day 0 (day of study procedure)
Difference in gait speed
Time frame: Day 0 (day of study procedure)
Difference in sit-to-stand test
Time frame: Day 0 (day of study procedure)
Difference in the incidence of osteoporosis
Time frame: Day 0 (day of study procedure)
Difference in the tendency to fall
Time frame: 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
Time frame: Day 0 (day of study procedure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 31419087Suetta 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.
- Individual participant dataSharing planned: No. For now no Individual Participant Data (IPD) are planned to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ditte Hansen, MD, PhD principal investigator
Department of Nephrology, Herlev and Gentofte Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Chronic Kidney Diseases, run by Herlev Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabina C Hauge, MD (+45 28965887, sabina.chaudhary.hauge@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in appendicular lean body mass (time frame: Day 0 (day of study procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04515342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.