NCT04271605

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

Terminated NA Results posted Last updated 18 June 2021

What this trial tests

NA trial testing diet and exercise suggestion in Osteoporosis, Postmenopausal in 5 participants. Terminated before completion.

Timeline

14 February 2020

Primary endpoint
2 December 2020

31 December 2020

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	14 February 2020
Primary completion	2 December 2020
Estimated completion	31 December 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• diet and exercise suggestion

Conditions studied

• Osteoporosis, Postmenopausal — all drugs for Osteoporosis, Postmenopausal →

Sponsor

National Taiwan University Hospital

Who can join

50 and older, any sex, with Osteoporosis, Postmenopausal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mortality, After Behavior Intervention and Pharmacological Therapy in Study Time Frame Primary · 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.

Group	Value	95% CI
Behavior Intervention and Pharmacological Therapy Group	0

Number of Participants With New-onset Cardiovascular Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame Primary · 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.

Group	Value	95% CI
Behavior Intervention and Pharmacological Therapy Group	0

Number of Participants With New-onset Fragility Fracture After Behavior Intervention and Pharmacological Therapy in Study Time Frame Primary · 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.

Group	Value	95% CI
Behavior Intervention and Pharmacological Therapy Group	0

Number of Fall Events After Behavior Intervention and Pharmacological Therapy in Study Time Frame Primary · 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.

Group	Value	95% CI
Behavior Intervention and Pharmacological Therapy Group	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bibliometric and visualized analysis of exercise and osteoporosis from 2002 to 2021.
   Li F, Xie W, Han Y, Li Z, et al · · 2022 · cited 8× · PMID 36569140 · DOI 10.3389/fmed.2022.944444