Clinical trial NCT04271605: Intervention on Osteoporosis and Chronic Kidney Disease-mineral and Bone Disorder (CKD-MBD)
Official title: The Effect of Multi-faceted Intervention on Osteoporosis and Mineral and Bone Disorder (CKD-MBD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Keywords: osteoporosis
chronic kidney disease
mineral-bone disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 5
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Behavior Intervention and Pharmacological Therapy
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality, After Behavior Intervention and Pharmacological Therapy in Study Time Frame
timeFrame: Through study termination, up to 45 weeks
measure: Number of Participants With New-onset Cardiovascular Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame
timeFrame: Through study termination, up to 45 weeks
measure: Number of Participants With New-onset Fragility Fracture After Behavior Intervention and Pharmacological Therapy in Study Time Frame
timeFrame: Through study termination, up to 45 weeks
measure: Number of Fall Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame
timeFrame: Through study termination, up to 45 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital, Chu-Tung Branch
Study officials:
affiliation: National Taiwan University Hospital, Chu-Tung Branch
name: Chirn-Bin Chang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: