Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395382
Status:
COMPLETED
Last Update Posted:
2010-02-09
First Post:
2006-11-01
Brief Title:
Study of the Effect of Alendronate on Vascular Calcification and Arterial Stiffness in Chronic Kidney Disease
Sponsor:
Monash University
Organization:
Monash University
Study Overview
Official Title:
Randomised Controlled Trial of the Effect of Alendronate on Vascular Calcification and Arterial Stiffness in Chronic Kidney Disease A Pilot Study
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiovascular disease CVD is the commonest cause of mortality in patients with chronic kidney disease CKD and end-stage kidney disease ESKD Reasons for the greater incidence of CVD in this group include traditional CVD risk factors of hypertension dyslipidemia and diabetes but more importantly also include non-traditional risk factors such as calcium and phosphate imbalance The latter is thought most likely to contribute to vascular calcification especially for those on dialysis and this in turn leads to arterial stiffness and left ventricular hypertrophy the two commonest cardiovascular complications Arterial stiffness and calcification have been found to be independent predictors of all-cause and cardiovascular mortality in CKD Few studies though have looked at both structural and functional changes associated with calcification and there have been very few interventional studies addressing this issue
Control of calcium and phosphate levels in CKD can occur with the use of medications that reduce elevated serum phosphate phosphate binders mostly calcium-based and those to treat hyperparathyroidism vitamin D and more recently calcium sensing receptor agonists called calcimimetics These pharmacological managements addressing calcium and phosphate imbalance reduce vascular calcification and CVD Bisphosphonate therapy may also have a role in reduction of calcification
Low bone mineral density BMD is common in CKD patients and predicts increased fracture risk similar to the general population Bisphosphonate therapy improves BMD and lowers the fracture risk Bisphosphonates may also have a role in secondary hyperparathyroidism to reduce hypercalcemia and allow for more aggressive calcitriol treatment Recent studies have addressed the possibility of bisphosphonates reducing the progression of vascular calcification in CKD and revealed that the extent of calcification may be suppressed in association with a reduction in chronic inflammatory responses
The investigators 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 59mlmin 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 the investigators aim to recruit about 50 patients 25 on alendronate and 25 control
Control of calcium and phosphate levels in CKD can occur with the use of medications that reduce elevated serum phosphate phosphate binders mostly calcium-based and those to treat hyperparathyroidism vitamin D and more recently calcium sensing receptor agonists called calcimimetics These pharmacological managements addressing calcium and phosphate imbalance reduce vascular calcification and CVD Bisphosphonate therapy may also have a role in reduction of calcification
Low bone mineral density BMD is common in CKD patients and predicts increased fracture risk similar to the general population Bisphosphonate therapy improves BMD and lowers the fracture risk Bisphosphonates may also have a role in secondary hyperparathyroidism to reduce hypercalcemia and allow for more aggressive calcitriol treatment Recent studies have addressed the possibility of bisphosphonates reducing the progression of vascular calcification in CKD and revealed that the extent of calcification may be suppressed in association with a reduction in chronic inflammatory responses
The investigators 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 59mlmin 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 the investigators aim to recruit about 50 patients 25 on alendronate and 25 control
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None