- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04271605
Intervention on Osteoporosis and Chronic Kidney Disease-mineral and Bone Disorder (CKD-MBD)
The Effect of Multi-faceted Intervention on Osteoporosis and Mineral and Bone Disorder (CKD-MBD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Older adults having chronic kidney disease (CKD) have a higher rate of fracture. Osteoporosis and chronic kidney disease mineral and bone disorder (CKD-MBD) are risk factors for skeletal fractures. However, most chronic kidney disease patients did not have data of bone mineral density before the recommendation of Kidney Disease: Improving Global Outcomes (KDIGO) guideline. The correlation of the CKD-MBD and osteoporosis was not fully elucidated. Also, the effect of a multifaceted intervention on those having both diseases was less studied.
Aims: To observe the clinical outcomes and the trends of biochemistry laboratory data before and after the multifaceted intervention Method: Sixty subjects with chronic kidney disease stage 3-4, and estimated glomerular filtration rate >20 mL/min/1.73m2 and high risk of fracture (FRAX screening: risk of hip fracture (HF) and major osteoporotic fracture (MOF) (HF: men>6%, women >7%; MOF: men>15%, women>12.5%) are enrolled.
Subjects received CKD-MBD and osteoporosis-related assessments, treatments, consultation on diet, medications, exercise. Followed assessments and interventions are conducted every 3 months.
Primary outcomes include one-year mortality, cardiovascular events, subsequent fracture, and fall events during the one-year intervention.
Secondary outcomes include trends of biochemistry laboratory data before and after interventions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hsinchu, Taiwan, 310
- National Taiwan University Hospital, Chu-Tung Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 50 years
- Chronic kidney disease stage 3-4, and estimated glomerular filtration rate > 20 mL/min/1.73m2
- Fracture Risk Assessment Tool (FRAX®) screening: risk of hip fracture (HF) and major osteoporotic fracture (MOF) (HF: men > 6%, women > 7%; MOF: men > 15%, women > 12.5%).
- Have ability to sign inform consent and agree with being follow-up for one year.
Exclusion Criteria:
- Have cancer under treatment.
- Have acute coronary syndrome (unstable angina, non ST-elevation myocardial infarction, ST-segment elevation myocardial infarction) or stroke in 3 months. (ST segment is the flat, isoelectric section of the ECG between the end of the S wave and the beginning of the T wave.)
- Limited cognitive or physical function for execute the intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: behavior intervention and pharmacological therapy
|
diet and exercise suggestion according to blood biochemistry data and bone mineral density
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality, After Behavior Intervention and Pharmacological Therapy in Study Time Frame
Time Frame: Through study termination, up to 45 weeks
|
A measure of the number of deaths in the participants with intervention during January 1, 2020 to December 31, 2020.
The mortality rate was calculated in percentage by the number of deaths during study period/all participants.
First participant was enrolled on February 14, 2020.
The study was terminated in December 31, 2020.
|
Through study termination, up to 45 weeks
|
Number of Participants With New-onset Cardiovascular Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame
Time Frame: Through study termination, up to 45 weeks
|
A measure of cardiovascular events of participants with intervention in January 1, 2020 to December 31, 2020.
It included acute coronary syndrome and acute stroke.
The cardiovascular event rate was calculated in percentage by the number of participants who had a new-onset of the cardiovascular event during study period/all participants.
First participant was enrolled on February 14, 2020.
The study was terminated in December 31, 2020.
|
Through study termination, up to 45 weeks
|
Number of Participants With New-onset Fragility Fracture After Behavior Intervention and Pharmacological Therapy in Study Time Frame
Time Frame: Through study termination, up to 45 weeks
|
New fracture was measured by participants' history and medical record of participants in January 1, 2020 to December 31, 2020.
Subsequent fragility fracture rate was calculated in percentage by number of participants who had a new-onset of fragility fracture during study period/all participants.
First participant was enrolled on February 14, 2020.
The study was terminated in December 31, 2020.
|
Through study termination, up to 45 weeks
|
Number of Fall Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame
Time Frame: Through study termination, up to 45 weeks
|
Fall episodes was measured by participants' history and medical record of participants in January 1, 2020 to December 31, 2020.
Fall rate was calculated in percentage by number of participants who had a new-onset of fall events during study period/all participants.
First participant was enrolled on February 14, 2020.
The study was terminated in December 31, 2020.
|
Through study termination, up to 45 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chirn-Bin Chang, M.D., National Taiwan University Hospital, Chu-Tung Branch
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 201909060RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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