Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.
Status:
Completed
Trial end date:
2019-11-28
Target enrollment:
Participant gender:
Summary
Aortic stenosis is a condition whereby one of the heart valves (aortic valve) becomes
narrowed, due to calcium deposition, over time. This can lead to chest pain, heart failure
and sudden death. It is the commonest valve disease requiring surgery in the developed world
and as the population becomes increasingly older, it is predicted that the prevalence of
aortic stenosis will double in the next 20 years. Currently the only treatment is replacement
of the aortic valve. Whilst this is excellent treatment, not everyone is suitable for it.
The primary objective of our study is to determine whether 2 drugs used in the treatment of
osteoporosis (a condition of bone thinning) can halt/retard the progression of aortic
stenosis. This is on the basis that studies have suggested that altered regulation of calcium
metabolism may be an important mechanism perpetuating the disease. Both drugs work by
reducing calcium release into the bloodstream from bones and therefore calcification of the
aortic valve.
150 patients will therefore be randomly allocated to either of the trial drugs which are
denosumab,the bisphosphonate (alendronic acid), or a placebo.
Positron Emission Tomography (PET) scanning is a technique where biochemically active
molecules are injected and are taken up at sites of ongoing calcification activity where they
emit radiation and can be detected by the PET scanner. We have previously shown that this
technique can demonstrate areas of newly developing calcification on an aortic valve.
We therefore propose that patients receiving bisphosphonates or denosumab will have reduced
evidence of active calcification and slower progression of their disease at two years as
assessed by Echocardiography (ultrasound) and a change in their calcium score (quantity of
calcium on the aortic valve measured using Computed Tomography [CT] ).
The data from this study will then be used to design a larger trial.