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The duration of grands was one year.
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Older adults having chronic kidney disease (CKD) have a higher rate of fracture than those without chronic kidney disease. Osteoporosis and chronic kidney disease mineral and bone disorder (CKD-MBD) are risk factors for skeletal fractures. In addition, CKD-MBD is also a risk factor for cardiovascular disease. Pharmacological and non-pharmacological therapy are both important to prevent complications of chronic kidney disease and osteoporosis. Therefore, a prospective intervention study is purposed to investigate the effect of a multifaceted intervention including exercise, diet modification, and pharmacological therapy on their outcomes. Patients who are older than 50 years old and have chronic kidney disease G3-G4 (estimated glomerular filtration rate > 20 ml/min per 1.73 m2) with a high risk of fracture (screening by Fracture Risk Assessment Tool (FRAX®)) are enrolled. Baseline questionnaire, clinical, laboratory and radiological examination are performed. If CKD-MBD or osteoporosis are revealed, the intervention will be given accordingly. All examinations will be repeated every 3 months, except bone mineral density and x-ray film for the spine to investigate the effect of the intervention. After one-year, primary outcomes including mortality, cardiovascular events, subsequent fracture, and fall rate will be examined. The secondary outcomes include changes in biochemistry laboratory data before and after interventions (pharmacological therapy and lifestyle modifications). The bivariate analysis will be performed using the t-test or Mann-Whitney U test for continuous variables with normal or non-normal distribution, respectively. Chi-squared test for categorical variables will be used to test correlations between baseline characteristics, change of laboratory results and outcomes. The paired t-test will be used to examine the difference between before and after the interventions. Stepwise multivariate logistic regression models will be used to identify the correlates of outcomes after adjusting for potential confounders.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| behavior intervention and pharmacological therapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet and exercise suggestion | Behavioral | diet and exercise suggestion according to blood biochemistry data and bone mineral density |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality, After Behavior Intervention and Pharmacological Therapy in Study Time Frame | 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 | 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 | 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chirn-Bin Chang, M.D. | National Taiwan University Hospital, Chu-Tung Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital, Chu-Tung Branch | Hsinchu | 310 | Taiwan |
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Exclusion criteria
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavior Intervention and Pharmacological Therapy | Patient enrollment Inclusion criteria
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Patient enrollment Inclusion criteria
Exclusion criteria
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality, After Behavior Intervention and Pharmacological Therapy in Study Time Frame | 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. | All participants enrolled were included in the analysis of mortality. | Posted | Count of Participants | Participants | Through study termination, up to 45 weeks |
|
Through study termination, up to 45 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavior Intervention and Pharmacological Therapy | Patient enrollment Inclusion criteria
Behavior therapy and pharmacological therapy were given in each clinic visit after participants enrolled. |
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This is a pilot study. The inclusion criteria was not applied in previous studies and limited patients could be identified as high risk of osteoporosis. We only enrolled limited number of patient and we terminated this study because the limit of funding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chirn-Bin Chang | National Taiwan University BioMedical Park Hospital Chu-Tung Campus | 0972654906 | G03776@hch.gov.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2019 | Jun 15, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2019 | Apr 27, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Behavior Intervention and Pharmacological Therapy
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| Through study termination, up to 45 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Bone mineral density | Bone mineral density was measured by dual energy x-ray absorptiometry. Most commonly, the test results are compared to the bone mineral density of a healthy young adult, and you are given a T-score. A score of 0 means participant's bone mineral density is equal to the norm for a healthy young adult. Differences between the participant's bone mineral density and that of the healthy young adult norm are measured in units as standard deviations. The more standard deviations below 0, indicated as negative numbers, the lower participant's bone mineral density and the higher the risk of fracture. | Mean | Standard Deviation | T-score |
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| Serum creatinine | Mean | Standard Deviation | mg/dL |
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| Serum phosphate | Mean | Standard Deviation | mg/dL |
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| Primary | Number of Participants With New-onset Cardiovascular Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame | 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. | All participants enrolled were included in the analysis of incidence of cardiovascular events. | Posted | Count of Participants | Participants | Through study termination, up to 45 weeks |
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| Primary | Number of Participants With New-onset Fragility Fracture After Behavior Intervention and Pharmacological Therapy in Study Time Frame | 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. | All participants enrolled were included in the analysis of subsequent fragility fracture rate. | Posted | Count of Participants | Participants | Through study termination, up to 45 weeks |
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| Primary | Number of Fall Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame | 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. | All participants enrolled were included in the analysis of number of fall events. | Posted | Count of Participants | Participants | Through study termination, up to 45 weeks |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |