- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515342
Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease
Sarcopenia, Fall and Osteoporosis in Patients With Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
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
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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
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Principal Investigator:
- Ditte Hansen, MD, PhD
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Sub-Investigator:
- Sabina C Hauge, MD
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Sub-Investigator:
- Anahita Rashid
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Sub-Investigator:
- Charlotte Suetta, MD,PhD,prof.
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Odense, Denmark, 5000
- Not yet recruiting
- Odense University Hospital
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Contact:
- Morten F Nielsen, MD, PhD
- Phone Number: +4522877448
- Email: mmfnielsen@health.sdu.dk
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Contact:
- Subagini Nagarajah, MD
- Phone Number: +4528598621
- Email: subagininagarajah3@rsyd.dk
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Principal Investigator:
- Morten F Nielsen, MD,PhD
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Sub-Investigator:
- Subagini Nagarajah, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
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.
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Each participant will undergo one DXA scan
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).
Each patient will undergo a physical examination and also deliver blood samples.
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What is the study measuring?
Primary Outcome Measures
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
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)
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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)
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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)
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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)
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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
Collaborators
Investigators
- Principal Investigator: Ditte Hansen, MD, PhD, Department of Nephrology, Herlev and Gentofte Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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