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Intervention on Osteoporosis and Chronic Kidney Disease-mineral and Bone Disorder (CKD-MBD)

NCT04271605 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-06-18

Study results available
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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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

BEHAVIORAL

diet and exercise suggestion

diet and exercise suggestion according to blood biochemistry data and bone mineral density

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chirn-Bin Chang, M.D. · National Taiwan University Hospital, Chu-Tung Branch

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2020-12-02
Completion
2020-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271605 on ClinicalTrials.gov