Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423384
Status:
UNKNOWN
Last Update Posted:
2010-03-24
First Post:
2007-01-17
Brief Title:
Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation
Sponsor:
Smerud Medical Research International AS
Organization:
Smerud Medical Research International AS
Study Overview
Official Title:
Ibandronate Versus Placebo as add-on to Active Vitamin D and Calcium in the Prevention of Bone Loss After Renal Transplantation
Status:
UNKNOWN
Status Verified Date:
2010-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Loss of bone mass is a common complication in patients with end-stage-renal failure both before and particularly after transplantation In addition to standard underlying therapy with calcium and active vitamin D we will study the effect of ibandronate a bisphosphonate versus placebo on bone mineral density as well as incidence of fracture rates after kidney transplantationWe also wish to study whether any prevented bone loss will also lead to reduced cardiovascular disease Patients will be followed for 12 months after transplantation and the ibandronate treatment is one injection every 3 months
Detailed Description:
Demographic medical history previous and current medication as well as baseline measurements of Bone Mineral Density BMD laboratory efficacy and safety variables as well as Quality-of-Life scores will be undertaken in the period from 1 week prior to transplantation until 1 week after transplantation In this period any existing fractures will be determined using traditional x-ray of the thoraco-lumbar columna Renal graft functioning as well as transplantation complications will be followed tightly and calcium supplementation as well as active vitamin D calcitriol will be administered together with the standard immunosuppressive regimen
As soon as patients have recovered from transplantation and renal functioning is considered sufficiently stable and no later than 28 days after the transplantation qualified patients will be randomised to receive either ibandronate or placebo stratified by gender Bone mineral density and most of the clinical data and laboratory tests will then be followed until 12 months after transplantation as described in the attached flowchart section 111 with hospital visits for administration of study drugs and follow-up of at 13 26 39 and 52 weeks after transplantation Furthermore all the patients will be followed prospectively from the time of transplantation and for ten years with regard to cardiovascular events Data concerning cardiovascular events will be collected from the Norwegian renal registry for the whole study population in the follow up period of about 10 years
As soon as patients have recovered from transplantation and renal functioning is considered sufficiently stable and no later than 28 days after the transplantation qualified patients will be randomised to receive either ibandronate or placebo stratified by gender Bone mineral density and most of the clinical data and laboratory tests will then be followed until 12 months after transplantation as described in the attached flowchart section 111 with hospital visits for administration of study drugs and follow-up of at 13 26 39 and 52 weeks after transplantation Furthermore all the patients will be followed prospectively from the time of transplantation and for ten years with regard to cardiovascular events Data concerning cardiovascular events will be collected from the Norwegian renal registry for the whole study population in the follow up period of about 10 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT no 2006-003884-30 | None | None | None |