Osteoporosis, Postmenopausal
Conditions
Keywords
osteoporosis, chronic kidney disease, mineral-bone disorder
Brief summary
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.
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.
Interventions
BEHAVIORALdiet and exercise suggestion
diet and exercise suggestion according to blood biochemistry data and bone mineral density
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Behavior Intervention and Pharmacological Therapy
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality, After Behavior Intervention and Pharmacological Therapy in Study 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. |
| Number of Participants With New-onset Cardiovascular Events After Behavior Intervention and Pharmacological Therapy in Study 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. |
| Number of Participants With New-onset Fragility Fracture After Behavior Intervention and Pharmacological Therapy in Study 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. |
| Number of Fall Events After Behavior Intervention and Pharmacological Therapy in Study 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. |
Countries
Taiwan
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group 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. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | The study was terminated because of the duration of funding was only one year. | 5 |
Baseline characteristics
| Characteristic | Intervention Group | — |
|---|---|---|
| Age, Continuous | 85.2 years STANDARD_DEVIATION 3.92 | — |
| Bone mineral density | -1.0 T-score STANDARD_DEVIATION 1.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Taiwan | 5 Participants | — |
| Serum creatinine | 1.6 mg/dL STANDARD_DEVIATION 0.2 | — |
| Serum phosphate | 3.5 mg/dL STANDARD_DEVIATION 0.1 | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: Through study termination, up to 45 weeks
Population: All participants enrolled were included in the analysis of mortality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavior Intervention and Pharmacological Therapy Group | Mortality, After Behavior Intervention and Pharmacological Therapy in Study Time Frame | 0 Participants |
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.
Time frame: Through study termination, up to 45 weeks
Population: All participants enrolled were included in the analysis of number of fall events.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavior Intervention and Pharmacological Therapy Group | Number of Fall Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame | 0 Participants |
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.
Time frame: Through study termination, up to 45 weeks
Population: All participants enrolled were included in the analysis of incidence of cardiovascular events.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavior Intervention and Pharmacological Therapy Group | Number of Participants With New-onset Cardiovascular Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame | 0 Participants |
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.
Time frame: Through study termination, up to 45 weeks
Population: All participants enrolled were included in the analysis of subsequent fragility fracture rate.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavior Intervention and Pharmacological Therapy Group | Number of Participants With New-onset Fragility Fracture After Behavior Intervention and Pharmacological Therapy in Study Time Frame | 0 Participants |