Effects of zoledronic acid on arterial calcification/stiffness Vers.1

• Research type

  Research Study

• Full title

  Effects of Zoledronic Acid on arterial calcification and arterial stiffness in women – a co-twin randomised double blind, placebo-controlled parallel group, clinical trial

• IRAS ID

  36053

• Contact name

  Phil Chowienczyk

• Sponsor organisation

  King’s College London

• Eudract number

  2010-019656-41

• ISRCTN Number

  xx

• Research summary

  Arterial stiffening is a condition where elasticity of the main artery walls is lost over time. It is caused by many different factors, some are reversible (high blood pressure) some are irreversible (age, genetic factors). Good elasticity and health of the arteries is important as it helps to reduce the risk of developing cardiovascular disease in later years. ??Vascular calcification?? (calcium in the artery walls) is related to arterial stiffening. Studies in animals show that a group of drugs called ??Bisphosphonates?? (well-tolerated drugs commonly used in individuals with a low bone mineral density) may help reduce the level of vascular calcification and so reduce arterial stiffness. A randomised control trial will take place to determine whether the Bisphosphonate ??Zoledronic Acid?? will reduce or halt the progression of vascular calcification and also how this affects the elasticity of the arteries. Female twin pairs, who have reduced bone mineral density, will be selected for this study. For each twin pair, one will be randomly allocated to annual infusions of zoledronic acid the other will receive a placebo for 3 years. For each annual visit, arterial stiffness will be recorded by pulse wave velocity (PWV), which measures the speed that a pulse travels between two sites. The pulse in the wrist will also be recorded. Subjects will then have a small blood sample taken. A CT scan, DEXA scan and ultrasound scan measuring arterial wall thickness and presence of calcium deposits will be performed at the first and last visit to assess how the drug has affected the arteries and bones.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/35

• Date of REC Opinion

  25 Aug 2010

• REC opinion

  Further Information Favourable Opinion