Study of the Effect of Alendronate on Vascular Calcification and Arterial Stiffness in Chronic Kidney Disease

We aim to perform a prospective, randomised study assessing the impact of alendronate on cardiovascular and bone mineral parameters. This will be a single-centre study involving subjects with CKD Stage 3 (those patients with GFR between 30 and 59ml/min). Arterial stiffness (by pulse wave analysis and pulse wave velocity) and vascular calcification (using CT scans through superficial femoral artery) will be followed as well as serum markers of calcium, phosphate and PTH. Differences in these end-points will be compared between participants taking alendronate and those not. The study will be conducted over a 12 month period and we aim to recruit about 50 patients (25 on alendronate and 25 control).

Official Title

Randomised Controlled Trial of the Effect of Alendronate on Vascular Calcification and Arterial Stiffness in Chronic Kidney Disease: A Pilot Study

Conditions

Chronic Kidney disease, Vascular Calcification, Arteriosclerosis

Study Type

Interventional

Study Design

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• Change in degree of arterial stiffness measured by pulse wave velocity
• Changes in vascular calcification on CT scans of superficial femoral artery and aorta

Secondary Outcome Measures:

• Changes in bone mineral density
• Changes in serum calcium and phosphate levels
• Cardiovascular events including myocardial ischaemia, myocardial infarction, cardiac failure, stroke, PVD
• Incidence of fractures
• Symptoms and severity of side effects from alendronate
• Episodes of hypocalcemia (serum corrected calcium <2.10mmol/L)

Study Start

January 2007; Expected completion: December 2008

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 85 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• Subjects with CKD Stage 3 (GFR between 30 and 59ml/min)
• Subjects must be 18 years of age or older
• Willingness to provide written informed consent

Exclusion Criteria:

• Subjects unable to give informed consent or whom have an expected life-span of less than 3 months
• Subjects undertaking renal replacement therapy (dialysis or transplantation)
• Subjects already taking bisphosphonates
• Subjects with recent fracture (within the last 3 months)
• Subjects scheduled to have a kidney transplant from a known living donor
• Subjects with active gastro-oesophageal reflux disease or peptic ulcer disease
• Subjects who are pregnant or planning on becoming pregnant in the next 18 months

Total Enrolment

50

Contact Details

Department of Nephrology, Monash Medical Centre, Clayton, Victoria, 3168, Australia; Recruiting

• Nigel D Toussaint, MBBS, FRACP; +61395943529, nigel.toussaint@med.monash.edu.au

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