Alendronate for Vascular Calcification in Peritoneal Dialysis Patients?
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|ClinicalTrials.gov Identifier: NCT00299572|
Recruitment Status : Unknown
Verified March 2006 by Far Eastern Memorial Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 7, 2006
Last Update Posted : March 7, 2006
|First Submitted Date ICMJE||March 5, 2006|
|First Posted Date ICMJE||March 7, 2006|
|Last Update Posted Date||March 7, 2006|
|Study Start Date ICMJE||March 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Alendronate for Vascular Calcification in Peritoneal Dialysis Patients?|
|Official Title ICMJE||Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients?|
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 factor(s) influencing the efficacy of alendronate. These results may help clinical physicians for early intervention and prevention of cardiovascular complications in ESRD patients.
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.
（3）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.
（4）Measurement 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.
（5）Measurement 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.
（6）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.
（7）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.
（8）Record of Adverse Effects of Alendronate Any adverse effect of alendronate is recorded every month at clinic visit. （9）Compliance of Patients Compliance of the patients is monitored by using telephone call once every week during the treatment period with alendronate.
（10）Statistical 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 0.05 is considered statistically significant.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Peritoneal Dialysis|
|Intervention ICMJE||Drug: alendronate (Fosamax)|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||December 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Taiwan|
|Removed Location Countries|
|NCT Number ICMJE||NCT00299572|
|Other Study ID Numbers ICMJE||94040|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Far Eastern Memorial Hospital|
|Collaborators ICMJE||Not Provided|
|PRS Account||Far Eastern Memorial Hospital|
|Verification Date||March 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP