Osteoporosis Prevention After Heart Transplant
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Rheumatology |
| Healthy: | No |
| Age Range: | 20 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | September 1997 |
| End Date: | April 2002 |
Prevention of Osteoporosis After Cardiac Transplantation
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.
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.
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 mg/day) and
placebo calcitriol. We will give Group B placebo alendronate and active calcitriol (0.25
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.
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 mg/day) and
placebo calcitriol. We will give Group B placebo alendronate and active calcitriol (0.25
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.
Inclusion Criteria:
- Cardiac transplantation
Exclusion Criteria:
- Active peptic ulcer disease, gastrectomy, inflammatory bowel disease, malignancy,
Paget's disease of bone, osteogenesis imperfecta, multiple myeloma, primary
hyperparathyroidism, rheumatoid arthritis, Cushing's syndrome, or thyrotoxicosis
- Suppressive doses of thyroid hormone, anticonvulsant drugs, past bisphosphonate
therapy, current calcitonin therapy, or fluoride therapy
- Cirrhosis, inflammatory liver disease, or nephrolithiasis
- Serum creatinine > 2.5 mg/dl
We found this trial at
2
sites
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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