Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261625
Status:
COMPLETED
Last Update Posted:
2009-01-05
First Post:
2005-12-01
Brief Title:
Can Alendronate Suppress Calcification and Improve Bone Density in Chronic Peritoneal Dialysis Patients
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
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:
Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women However its safety and efficacy in increasing bone mineral density in chronic peritoneal dialysis PD patients have not been investigated Etidronate another bisphosphonate can suppress the extent of coronary artery calcification in chronic hemodialysis patients The hypothesis of this study is that alendronate can increase bone mineral density and suppress aortic and coronary artery calcification in chronic peritoneal dialysis patients
Detailed Description:
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 in the first 24 weeks of the study while group 2 patients receive the same dose of drug every week in the second 24 weeks The extent of coronary artery and aortic calcification is evaluated by using multidetector spiral computed tomography whereas bone mineral density is measured by dual-energy X-ray absorptiometry Both examinations are performed at week 0 24 and 48 for each participant Serum level of calcium should be kept within normal limits and serum level of phosphorus should be kept below 6 mgdl
Administration 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
Measurement of Coronary Artery and Aortic Calcification
Multidetector spiral computerized tomography CT of the chest is performed at week 0 24 and 48 for each participant to measure the extent of coronary and aortic calcification
Measurement of Bone Density
Dual energy X-ray absorptiometry is performed at week 0 24 and 48 for each participant to measure the density of bone
Demographic 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
Collection 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
Record of Adverse Effects of Alendronate
Any adverse effect of alendronate is recorded every month at clinic visit
Compliance of Patients
Compliance of the patients is monitored using telephone calls once every week during the treatment period with alendronate
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 in the first 24 weeks of the study while group 2 patients receive the same dose of drug every week in the second 24 weeks The extent of coronary artery and aortic calcification is evaluated by using multidetector spiral computed tomography whereas bone mineral density is measured by dual-energy X-ray absorptiometry Both examinations are performed at week 0 24 and 48 for each participant Serum level of calcium should be kept within normal limits and serum level of phosphorus should be kept below 6 mgdl
Administration 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
Measurement of Coronary Artery and Aortic Calcification
Multidetector spiral computerized tomography CT of the chest is performed at week 0 24 and 48 for each participant to measure the extent of coronary and aortic calcification
Measurement of Bone Density
Dual energy X-ray absorptiometry is performed at week 0 24 and 48 for each participant to measure the density of bone
Demographic 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
Collection 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
Record of Adverse Effects of Alendronate
Any adverse effect of alendronate is recorded every month at clinic visit
Compliance of Patients
Compliance of the patients is monitored using telephone calls once every week during the treatment period with alendronate
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