Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000412
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
1999-11-03
Brief Title:
Osteoporosis Prevention After Heart Transplant
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Prevention of Osteoporosis After Cardiac Transplantation
Status:
COMPLETED
Status Verified Date:
2015-07
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:
During the first year after a heart transplant people often rapidly lose bone from their spine and hips About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation This study will compare the safety and effectiveness of the drug alendronate Fosamax and the active form of vitamin D calcitriol in preventing bone loss at the spine and hip after a heart transplant
In this study people who have had a successful heart transplant will receive either active alendronate and a dummy pill instead of calcitriol or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant starting within 1 month after transplant surgery We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months and will also check for broken bones in the spine This research should lead to ways of preventing this crippling form of osteoporosis
In this study people who have had a successful heart transplant will receive either active alendronate and a dummy pill instead of calcitriol or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant starting within 1 month after transplant surgery We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months and will also check for broken bones in the spine This research should lead to ways of preventing this crippling form of osteoporosis
Detailed Description:
We will enroll patients who have undergone cardiac transplantation into a randomized double-blind 12-month study of the efficacy and safety of calcitriol Rocaltrol and alendronate sodium Fosamax in the prevention of bone loss after transplantation We will give all participants standard pre- and post-transplantation management and immunosuppressive therapy three tablets of calcium citrate Citracal D each containing 315 mg of elemental calcium and 200 IU of vitamin D and a multivitamin providing 400 units of vitamin D daily We will randomize participants to one of two active treatment groups within 1 month of transplantation We will give Group A active alendronate 10 mgday and placebo calcitriol We will give Group B placebo alendronate and active calcitriol 025 micrograms BID The primary efficacy endpoint is the change in spine bone mineral density BMD during the first 6 months after transplantation The secondary efficacy endpoint is the change in hip BMD during the first year after transplantation We will also monitor the incidence of vertebral fracture
We will invite eligible subjects to participate in the study We will offer patients who elect not to participate in the therapeutic trial the opportunity to have serial BMD measurements at the same intervals as treated subjects and to be followed as untreated controls We will continue recruitment until we have randomized a total of 146 cardiac transplant recipients We will perform bone densitometry at randomization unless performed within the previous month and at 6 and 12 months We will obtain radiographs x-rays at randomization and will repeat them at 12 months to detect undiagnosed vertebral fractures
We will invite eligible subjects to participate in the study We will offer patients who elect not to participate in the therapeutic trial the opportunity to have serial BMD measurements at the same intervals as treated subjects and to be followed as untreated controls We will continue recruitment until we have randomized a total of 146 cardiac transplant recipients We will perform bone densitometry at randomization unless performed within the previous month and at 6 and 12 months We will obtain radiographs x-rays at randomization and will repeat them at 12 months to detect undiagnosed vertebral fractures
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 |
|---|---|---|---|
| R01AR046124 | NIH | None | None |
| NIAMS-008 | OTHER | NIAMS | httpsreporternihgovquickSearchR01AR046124 |