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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Older adults having chronic kidney disease (CKD) have a higher rate of fracture than those without CKD. Osteoporosis and chronic kidney disease mineral-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 CKD 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 CKD G3-G4 (eGFR > 20 ml/min per 1.73 m2) with a high risk of fracture (screening by FRAX®) are enrolled. Baseline questionnaire, clinical, laboratory and radiologic 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.

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Behavioral: diet and exercise suggestion Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: behavior intervention and pharmacological therapy
  • For participants with abnormal biochemical markers, pharmacological therapy and diet modification are applied.
  • Dietary education on phosphorus additives is applied specifically for retention of phosphorus or high serum phosphorus level.
  • Exercise for bone and cardiovascular health.
  • Osteoporosis medications are initiated according to the reimbursed criteria of National Health Insurance, otherwise medications are used with non-insurance payment.
Behavioral: diet and exercise suggestion
diet and exercise suggestion according to blood biochemistry data and BMD




Primary Outcome Measures :
  1. one-year mortality, after 1-year behavior intervention [ Time Frame: 1 year ]
  2. Incidence of cardiovascular events (episodes of the acute coronary syndrome and acute stroke) [ Time Frame: 1 year ]
  3. subsequent fragility fracture rate (from patients' history and medical record) [ Time Frame: 1 year ]
  4. Number of fall events (from patients' history and medical record) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 50 years
  • CKD stage 3-4, and eGFR > 20 mL/min/1.73m2
  • 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 elevation myocardial infarction) or stroke in 3 months.
  • Limited cognitive or physical function for execute the intervention.

Information from the National Library of Medicine

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


Contacts
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Contact: Chirn-Bin Chang, M.D. 886-3-5943248 ext 1031 C20131@chut.ntuh.gov.tw

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chirn-Bin Chang, M.D. National Taiwan University Hospital, Chu-Tung Branch

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04271605    
Other Study ID Numbers: 201909060RINA
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
osteoporosis
chronic kidney disease
mineral-bone disorder
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases