Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease

April 19, 2024 updated by: Ditte Hansen, Herlev Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital, Herlev Hospital
        • Contact:
        • Contact:
        • 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:
        • Contact:
        • Principal Investigator:
          • Morten F Nielsen, MD,PhD
        • Sub-Investigator:
          • Subagini Nagarajah, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 0 (day of study procedure)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in the incidence of sarcopenia
Time Frame: 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
Day 0 (day of study procedure)
Difference in appendicular muscle mass
Time Frame: 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
Day 0 (day of study procedure)
Difference in handgrip strength
Time Frame: 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
Day 0 (day of study procedure)
Difference in gait speed
Time Frame: 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
Day 0 (day of study procedure)
Difference in sit-to-stand test
Time Frame: 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
Day 0 (day of study procedure)
Difference in the incidence of osteoporosis
Time Frame: 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
Day 0 (day of study procedure)
Difference in the tendency to fall
Time Frame: 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
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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Herlev Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ditte Hansen, MD, PhD, Department of Nephrology, Herlev and Gentofte Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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