Trial Outcomes & Findings for Intervention on Osteoporosis and Chronic Kidney Disease-mineral and Bone Disorder (CKD-MBD) (NCT NCT04271605)
NCT ID: NCT04271605
Last Updated: 2021-06-18
Results Overview
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.
TERMINATED
NA
5 participants
Through study termination, up to 45 weeks
2021-06-18
Participant Flow
Patient who are Aged \> 50 years and having chronic kidney disease stage 3-4, and estimated glomerular filtration rate \>20 mL/min/1.73m2 in clinics of study investigators were asked to participate this study. If participants did not have conditions for exclusion and agreed with this follow-up visits, they were enrolled.
Exclusion criteria 1. Have cancer under treatment. 2. Have acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction, ST-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.) 3. Limited cognitive or physical function for execute the intervention.
Participant milestones
| Measure |
Behavior Intervention and Pharmacological Therapy
Patient enrollment Inclusion criteria
1. Age more than 50 years
2. Chronic kidney disease stage 3-4, and estimated glomerular filtration rate \>20 mL/min/1.73m2
3. 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%).
4. Have ability to sign inform consent and agree with being follow-up for one year.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Behavior Intervention and Pharmacological Therapy
Patient enrollment Inclusion criteria
1. Age more than 50 years
2. Chronic kidney disease stage 3-4, and estimated glomerular filtration rate \>20 mL/min/1.73m2
3. 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%).
4. Have ability to sign inform consent and agree with being follow-up for one year.
|
|---|---|
|
Overall Study
The study was terminated because of the duration of funding was only one year.
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=5 Participants
Patient enrollment Inclusion criteria
1. Age more than 50 years
2. Chronic kidney disease stage 3-4, and estimated glomerular filtration rate \>20 mL/min/1.73m2
3. 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%).
4. Have ability to sign inform consent and agree with being follow-up for one year.
Exclusion criteria
1. Have cancer under treatment.
2. Have acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction, ST-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.)
3. Limited cognitive or physical function for execute the intervention.
|
|---|---|
|
Age, Continuous
|
85.2 years
STANDARD_DEVIATION 3.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
5 Participants
n=5 Participants
|
|
Bone mineral density
|
-1.0 T-score
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Serum creatinine
|
1.6 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Serum phosphate
|
3.5 mg/dL
STANDARD_DEVIATION 0.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through study termination, up to 45 weeksPopulation: All participants enrolled were included in the analysis of mortality.
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.
Outcome measures
| Measure |
Behavior Intervention and Pharmacological Therapy Group
n=5 Participants
Patient enrollment Inclusion criteria
1. Age more than 50 years
2. Chronic kidney disease stage 3-4, and estimated glomerular filtration rate \>20 mL/min/1.73m2
3. 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%).
4. Have ability to sign inform consent and agree with being follow-up for one year.
Behavior therapy and pharmacological therapy were given in each clinic visit after participants enrolled.
|
|---|---|
|
Mortality, After Behavior Intervention and Pharmacological Therapy in Study Time Frame
|
0 Participants
|
PRIMARY outcome
Timeframe: Through study termination, up to 45 weeksPopulation: All participants enrolled were included in the analysis of incidence of cardiovascular events.
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.
Outcome measures
| Measure |
Behavior Intervention and Pharmacological Therapy Group
n=5 Participants
Patient enrollment Inclusion criteria
1. Age more than 50 years
2. Chronic kidney disease stage 3-4, and estimated glomerular filtration rate \>20 mL/min/1.73m2
3. 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%).
4. Have ability to sign inform consent and agree with being follow-up for one year.
Behavior therapy and pharmacological therapy were given in each clinic visit after participants enrolled.
|
|---|---|
|
Number of Participants With New-onset Cardiovascular Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame
|
0 Participants
|
PRIMARY outcome
Timeframe: Through study termination, up to 45 weeksPopulation: All participants enrolled were included in the analysis of subsequent fragility fracture rate.
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.
Outcome measures
| Measure |
Behavior Intervention and Pharmacological Therapy Group
n=5 Participants
Patient enrollment Inclusion criteria
1. Age more than 50 years
2. Chronic kidney disease stage 3-4, and estimated glomerular filtration rate \>20 mL/min/1.73m2
3. 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%).
4. Have ability to sign inform consent and agree with being follow-up for one year.
Behavior therapy and pharmacological therapy were given in each clinic visit after participants enrolled.
|
|---|---|
|
Number of Participants With New-onset Fragility Fracture After Behavior Intervention and Pharmacological Therapy in Study Time Frame
|
0 Participants
|
PRIMARY outcome
Timeframe: Through study termination, up to 45 weeksPopulation: All participants enrolled were included in the analysis of number of fall events.
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.
Outcome measures
| Measure |
Behavior Intervention and Pharmacological Therapy Group
n=5 Participants
Patient enrollment Inclusion criteria
1. Age more than 50 years
2. Chronic kidney disease stage 3-4, and estimated glomerular filtration rate \>20 mL/min/1.73m2
3. 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%).
4. Have ability to sign inform consent and agree with being follow-up for one year.
Behavior therapy and pharmacological therapy were given in each clinic visit after participants enrolled.
|
|---|---|
|
Number of Fall Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame
|
0 Participants
|
Adverse Events
Behavior Intervention and Pharmacological Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chirn-Bin Chang
National Taiwan University BioMedical Park Hospital Chu-Tung Campus
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place