Intervention on Osteoporosis and CKD-MBD
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|ClinicalTrials.gov Identifier: NCT04271605|
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis, Postmenopausal||Behavioral: diet and exercise suggestion||Not Applicable|
Background: Older adults having chronic kidney disease (CKD) have a higher rate of fracture. Osteoporosis and chronic kidney disease mineral-bone disorder (CKD-MBD) are risk factors for skeletal fractures. However, most CKD patients did not have data of bone mineral density before the recommendation of 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 CKD stage 3-4, and eGFR >20 mL/min/1.73m2 and high risk of fracture (FRAX screening: risk of hip fracture (HF) and major osteoporotic fracture (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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Multi-faceted Intervention on Osteoporosis and CKD-MBD|
|Estimated Study Start Date :||February 20, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 21, 2021|
Experimental: behavior intervention and pharmacological therapy
Behavioral: diet and exercise suggestion
diet and exercise suggestion according to blood biochemistry data and BMD
- one-year mortality, after 1-year behavior intervention [ Time Frame: 1 year ]
- Incidence of cardiovascular events (episodes of the acute coronary syndrome and acute stroke) [ Time Frame: 1 year ]
- subsequent fragility fracture rate (from patients' history and medical record) [ Time Frame: 1 year ]
- Number of fall events (from patients' history and medical record) [ Time Frame: 1 year ]
- trends of renal function after 1-year behavior intervention [ Time Frame: 1 year ]measurement of renal function (e.g., serum creatinine) before and after interventions
- trends of biochemistry laboratory data for diagnosing CKD-MBD after 1-year behavior intervention [ Time Frame: 1 year ]measurement of biochemistry laboratory data (e.g.,calcium, phosphate, vitamin D) before and after interventions
- trends of cardiovascular disease risk factor for CKD-MBD after 1-year behavior intervention [ Time Frame: 1 year ]measurement of laboratory data as the cardiovascular diseases risk factor (e.g.,hs-CRP) before and after interventions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271605
|Contact: Chirn-Bin Chang, M.D.||886-3-5943248 ext 1031||C20131@chut.ntuh.gov.tw|
|Principal Investigator:||Chirn-Bin Chang, M.D.||National Taiwan University Hospital, Chu-Tung Branch|