Can Alendronate Suppress Calcification and Improve Bone Density in Chronic Peritoneal Dialysis Patients?
Condition: End-Stage Renal Disease; Osteoporosis
MeSH terms: Osteoporosis; Kidney Failure, Chronic; Calcinosis
Study type: Interventional
Phase: Phase 4

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 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
      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.
    

Intervention name(s): alendronate
Intervention type(s): Drug
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peritoneal dialysis; artery calcification; bone mineral density