Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women. However, its safty and efficacy in increasing bone mineral density in chronic peritoneal dialysis patients have not been investigated. Etiodronate, 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.

Condition	Intervention	Phase
End-Stage Renal Disease Peritoneal Dialysis Osteoporosis	Drug: alendronate	Phase IV

Further study details as provided by National Taiwan University Hospital:

Primary Outcomes: 1. extent of aortic and coronary artery calcification with and without the use of alendronate; 2. bone mineral density with and without the use of alendronate
Secondary Outcomes: serum levels of calcium, phosphorus and parathyroid hormone
Expected Total Enrollment:  50

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 mg/dl.

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 pararthyroid 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 cholersterol (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 by using telephone call once every week during the treatment period with alendronate.

Ages Eligible for Study:  20 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• (1) have received maintenance PD for more than 3 months at National Taiwan University Hospital, (2) have high CPP level (≧50), and (3) have chest X-ray proven aortic calcification or coronary artery calcification proven before.

Exclusion Criteria:

• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00261625

Tze-Wah Kao, Master      886-2-23123456  Ext. 7790 or 2919    twkao@ha.mc.ntu.edu.tw

Study chairs or principal investigators

Tze-Wah Kao, master,  Principal Investigator,  National Taiwan University   

Study ID Numbers:  940706
Last Updated:  December 8, 2005
Record first received:  December 1, 2005
ClinicalTrials.gov Identifier:  NCT00261625
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2006-01-10