Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299572
Status:
UNKNOWN
Last Update Posted:
2006-03-07
First Post:
2006-03-05
Brief Title:
Alendronate for Vascular Calcification in Peritoneal Dialysis Patients
Sponsor:
Far Eastern Memorial Hospital
Organization:
Far Eastern Memorial Hospital
Study Overview
Official Title:
Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients
Status:
UNKNOWN
Status Verified Date:
2006-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hyperphosphatemia is frequently seen in patients with end-stage renal disease ESRD Hyperphosphatemia usually results in a high calcium-phosphorus product CPP which may subsequently lead to artery and become a risk factor of cardiovascular complications Alendronate due to its effect of inhibiting osteoclasts is approved for treatment of osteoporosis Previous reports found the use of bisphosphonates could suppress arterial calcification in hemodialysis dialysis patients The aim of this study is to evaluate the safety and efficacy of alendronate to suppress coronary artery and aortic calcifications as well as to improve bone density in chronic peritoneal dialysis PD patients
This study will include ESRD patients who had received maintenance PD for more than 3 months have high CPP level 55 and have chest X-ray proven aortic calcification or coronary artery calcification All participants are randomly allocated to either group 1 or group 2 Group 1 patients receive alendronate 70 mg once weekly in the first 16 weeks while group 2 patients receive the same dose of drug every week in the second 16 weeks The extent of coronary artery and aortic calcification is evaluated by using multi-detector spiral computed tomography whereas bone mineral density is measured by dual-energy X-ray absorptiometry Both examinations are performed at week 0 16 and 32 for each participant Laboratory studies and possible adverse reactions were regularly monitored
We expect that alendronate can alleviate the progression of arterial calcification or even improve it Bone density may also be improved after treatment Besides we wish to find the independent factors influencing the efficacy of alendronate These results may help clinical physicians for early intervention and prevention of cardiovascular complications in ESRD patients
This study will include ESRD patients who had received maintenance PD for more than 3 months have high CPP level 55 and have chest X-ray proven aortic calcification or coronary artery calcification All participants are randomly allocated to either group 1 or group 2 Group 1 patients receive alendronate 70 mg once weekly in the first 16 weeks while group 2 patients receive the same dose of drug every week in the second 16 weeks The extent of coronary artery and aortic calcification is evaluated by using multi-detector spiral computed tomography whereas bone mineral density is measured by dual-energy X-ray absorptiometry Both examinations are performed at week 0 16 and 32 for each participant Laboratory studies and possible adverse reactions were regularly monitored
We expect that alendronate can alleviate the progression of arterial calcification or even improve it Bone density may also be improved after treatment Besides we wish to find the independent factors influencing the efficacy of alendronate These results may help clinical physicians for early intervention and prevention of cardiovascular complications in ESRD patients
Detailed Description:
OBJECTIVES The purpose of this study is to determine if long-term use of alendronate can suppress coronary artery and aortic calcification in chronic PD patients The effect of alendronate on bone mineral density in this patient group is also evaluated
METHODS
1 Patients To be eligible for the study patients have to meet all of the following criteria 1 have received maintenance PD for more than 3 months at Far Eastern Memorial Hospital 2 have high CPP level 55 and 3 have chest X-ray proven aortic calcification or coronary artery calcification proven before Patients are excluded if they have any one of the following conditions 1 had been hospitalized in recent 3 months due to severe comorbid diseases 2 are hypersensitive to alendronate or any of its components 3 have esophageal diseases 4 are not able to stand or sit upright for 30 minutes 5 have refractory hypocalcemia or 6 patients who are pregnant
Each eligible participant has to give hisher written informed consent before the start of study The study should be approved by the Institutional Review Board of the hospital
2 Study Design The study is a prospective randomized cross-over study Fifty patients will be included All participants are randomly allocated to either group 1 or group 2 Each group consists of 25 patients Group 1 patients receive alendronate 70 mg once weekly since the first week till the 16th week of the study while group 2 patients receive the same dose of drug every week since the 17th week till the 32nd week Group 1 patients will not receive alendronate since the 17th week till the 32nd week and group 2 patients will not receive alendronate since the first week till the 16 week The extent of coronary artery and aortic calcification is evaluated by using multi-detector spiral computed tomography whereas bone mineral density is measured by dual-energy X-ray absorptiometry Both examinations are performed at week 0 16 and 32 for each participant Serum level of calcium should be kept within normal limits and serum level of phosphorus should be kept below 6 mgdl
3Administration of Alendronate One tablet of alendronate 70 mg per tablet should be swallowed by each patient once every week with water at least 30 minutes before breakfast beverage or medication of the day during the treatment period Patients must not lie down for at least 30 minutes after taking the drug
4Measurement of Coronary Artery and Aortic Calcification Multi-detector spiral computerized tomography CT of the chest is performed at week 0 16 and 32 for each participant to measure the extent of coronary and aortic calcification
5Measurement of Bone Density Dual energy X-ray absorptiometry is performed at week 0 16 and 32 for each participant to measure the density of bone
6Demographic and Clinical Characteristics of Patients Patients characteristics such as age and sex are documented Clinical parameters including body height body weight duration of dialysis calcium concentration of dialysate and medication under use are recorded Blood pressure is measured at each clinical visit for 3 times after the patient has sit for at least 15 minutes
7Collection of Laboratory Data Fasting serum levels of albumin phosphorus calcium alkaline phosphatase ALP intact parathyroid hormone iPTH and hemoglobin level of each patient are checked at study entry and once every month Fasting serum levels of triglyceride total cholesterol high-density lipoprotein cholesterol HDL-chol low-density lipoprotein cholesterol LDL-chol and hypersensitive C-reactive protein CRP of each patient are checked at study entry and once every 3 months
8Record of Adverse Effects of Alendronate Any adverse effect of alendronate is recorded every month at clinic visit 9Compliance of Patients Compliance of the patients is monitored by using telephone call once every week during the treatment period with alendronate
10Statistical Analysis All values are expressed as mean SD All data are tested for normal distribution before analysis Differences between mean values of the 2 groups are tested by means of analysis of variance Group comparisons of categorical variables are analyzed using chi-square test Multivariate regression is applied to identify independent determinants of coronary artery and aortic calcification A probability less than 005 is considered statistically significant
METHODS
1 Patients To be eligible for the study patients have to meet all of the following criteria 1 have received maintenance PD for more than 3 months at Far Eastern Memorial Hospital 2 have high CPP level 55 and 3 have chest X-ray proven aortic calcification or coronary artery calcification proven before Patients are excluded if they have any one of the following conditions 1 had been hospitalized in recent 3 months due to severe comorbid diseases 2 are hypersensitive to alendronate or any of its components 3 have esophageal diseases 4 are not able to stand or sit upright for 30 minutes 5 have refractory hypocalcemia or 6 patients who are pregnant
Each eligible participant has to give hisher written informed consent before the start of study The study should be approved by the Institutional Review Board of the hospital
2 Study Design The study is a prospective randomized cross-over study Fifty patients will be included All participants are randomly allocated to either group 1 or group 2 Each group consists of 25 patients Group 1 patients receive alendronate 70 mg once weekly since the first week till the 16th week of the study while group 2 patients receive the same dose of drug every week since the 17th week till the 32nd week Group 1 patients will not receive alendronate since the 17th week till the 32nd week and group 2 patients will not receive alendronate since the first week till the 16 week The extent of coronary artery and aortic calcification is evaluated by using multi-detector spiral computed tomography whereas bone mineral density is measured by dual-energy X-ray absorptiometry Both examinations are performed at week 0 16 and 32 for each participant Serum level of calcium should be kept within normal limits and serum level of phosphorus should be kept below 6 mgdl
3Administration of Alendronate One tablet of alendronate 70 mg per tablet should be swallowed by each patient once every week with water at least 30 minutes before breakfast beverage or medication of the day during the treatment period Patients must not lie down for at least 30 minutes after taking the drug
4Measurement of Coronary Artery and Aortic Calcification Multi-detector spiral computerized tomography CT of the chest is performed at week 0 16 and 32 for each participant to measure the extent of coronary and aortic calcification
5Measurement of Bone Density Dual energy X-ray absorptiometry is performed at week 0 16 and 32 for each participant to measure the density of bone
6Demographic and Clinical Characteristics of Patients Patients characteristics such as age and sex are documented Clinical parameters including body height body weight duration of dialysis calcium concentration of dialysate and medication under use are recorded Blood pressure is measured at each clinical visit for 3 times after the patient has sit for at least 15 minutes
7Collection of Laboratory Data Fasting serum levels of albumin phosphorus calcium alkaline phosphatase ALP intact parathyroid hormone iPTH and hemoglobin level of each patient are checked at study entry and once every month Fasting serum levels of triglyceride total cholesterol high-density lipoprotein cholesterol HDL-chol low-density lipoprotein cholesterol LDL-chol and hypersensitive C-reactive protein CRP of each patient are checked at study entry and once every 3 months
8Record of Adverse Effects of Alendronate Any adverse effect of alendronate is recorded every month at clinic visit 9Compliance of Patients Compliance of the patients is monitored by using telephone call once every week during the treatment period with alendronate
10Statistical Analysis All values are expressed as mean SD All data are tested for normal distribution before analysis Differences between mean values of the 2 groups are tested by means of analysis of variance Group comparisons of categorical variables are analyzed using chi-square test Multivariate regression is applied to identify independent determinants of coronary artery and aortic calcification A probability less than 005 is considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None