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Osteoporosis Prevention After Heart Transplant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000412
First Posted: November 4, 1999
Last Update Posted: July 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Columbia University
  Purpose

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.


Condition Intervention Phase
Osteoporosis Cardiac Transplantation Drug: Alendronate Drug: Calcitriol Drug: Placebo Alendronate Drug: Placebo Calcitriol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Osteoporosis After Cardiac Transplantation

Resource links provided by NLM:


Further study details as provided by Columbia University:

Enrollment: 149
Study Start Date: September 1997
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Group A active alendronate (10 mg/day) and placebo calcitriol.
Drug: Alendronate Drug: Placebo Calcitriol
Placebo Comparator: Group B
We will give Group B placebo alendronate and active calcitriol (0.25 micrograms BID).
Drug: Calcitriol Drug: Placebo Alendronate

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 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.

  Eligibility

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000412


Locations
United States, New York
Columbai University Medical Center
New York, New York, United States, 10032
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Elizabeth Shane, MD Columbia University Department of Medicine
  More Information

Publications:
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00000412     History of Changes
Other Study ID Numbers: R01AR046124 ( U.S. NIH Grant/Contract )
NIAMS-008 ( Other Identifier: NIAMS )
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Columbia University:
Osteoporosis
Osteopenia
Heart transplant
Bone fracture
Bone density
Dual energy x-ray absorptiometry

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Calcitriol
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances