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Pamidronate, Vitamin D, and Calcium for the Bone Disease of Kidney and Heart Transplantation

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ClinicalTrials.gov Identifier: NCT00302627
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : August 26, 2010
The Heart Institute of Spokane
Ochsner Health System
University of Washington
Information provided by:
Providence Health & Services

Brief Summary:
Bone is lost rapidly and fractures occur in 10-20% of patients who receive organ transplants within 2 years. The purpose of this study is to evaluate long-term effects of a pamidronate-vitamin D-calcium regimen on bone loss, fractures, and safety in recipients of kidney and heart transplants.

Condition or disease Intervention/treatment
Transplant Bone Disease Drug: Pamidronate Drug: vitamin D Drug: calcium supplement

Detailed Description:

Pamidronate improves bone mass in numerous disorders of bone. Other bisphosphonates, as well as pamidronate, have been proven to be beneficial in steroid-related bone disorders. Steroid treatment is a major cause of bone loss after organ transplantation. Small, short-term studies suggest that pamidronate prevents bone loss in kidney and heart transplant recipients.

Many bisphosphonates cannot be used in patients with decreased kidney function. However, pamidronate can be given to these patients. This is an advantage of pamidronate in kidney and heart transplantation because of the frequent occurrence of decreased kidney function in these groups. Another advantage of pamidronate is that it is administered intravenously. Oral bisphosphonates commonly produce esophagitis, which is a challenging problem in the transplant population. Potential side-effects of pamidronate include transient hypocalcemia, lymphopenia, low-grade fever, myalgias and nausea. Recently, rare cases of proteinuria and kidney failure were reported in cancer patients receiving high-dose pamidronate. Although this side effect has not been reported in other types of patients receiving pamidronate, this is a safety concern that warrants further scrutiny in the transplant population.

In addition to bisphosphonate treatment, supplementation with calcium and vitamin D may preserve bone after organ transplantation. Prior studies have compared bisphosphonates to calcium and vitamin D regimens. However, a combination regimen including each of these treatments may preserve bone mass better than a single treatment. Data regarding treatment with a combination of a bisphosphonate, calcium, and vitamin D are lacking in kidney and heart transplantation.

Comparison(s): In a prospective, open-label, single arm trial, Pamidronate (60-90 mg) is administered within 2 weeks after kidney or heart transplant and every 6 months for 2 years. Participants are prescribed vitamin D 800 units/d or calcitriol 0.25 microgram/d if serum creatinine is greater than 2 mg/dl, and calcium carbonate 1500 mg/d.

The primary outcome is bone mineral density measured by dual-energy X-ray absorptiometry at baseline and after years 1 and 2. Fracture events and serum calcium, parathyroid hormone, creatinine, and dipstick proteinuria are also measured.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pamidronate, Vitamin D, and Calcium for the Bone Disease of Kidney and Heart Transplantation
Study Start Date : January 1999
Primary Completion Date : November 2002
Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pamidronate Infusion Drug: Pamidronate
60mg or 90mg given at baseline, 6,12,18, and 24 months
Other Name: Transplant Bone Disease
Drug: vitamin D
baseline, 6,12 months
Other Name: Vitamin D administration in Transplant
Drug: calcium supplement
baseline, 6,12 months
Other Name: Calcium administration in Transplant

Primary Outcome Measures :
  1. Bone mineral density measured by dual-energy X-ray absorptiometry [ Time Frame: Every 12 months ]
    Performed at 1 year and 2 years.

Secondary Outcome Measures :
  1. Fracture events [ Time Frame: Every 6 months ]
    Evaluated at 6, 12, 18 months and 2 years

  2. serum calcium [ Time Frame: Every 6 months ]
    baseline, 6,12,18 months and 2 years

  3. parathyroid hormone [ Time Frame: Every 6 months ]
    baseline, 6,12,18 months and 2 years

  4. serum creatinine and estimated glomerular filtration rate [ Time Frame: Every 6 months ]
    Performed at 6,12,18 months and 2 years

  5. proteinuria [ Time Frame: Every 6 months ]
    Evaluated at 6,12,18 months and 2 years

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Kidney or heart transplant recipients

Exclusion Criteria:

  • Hyperparathyroidism

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): NCT00302627

United States, Washington
Providence Medical Research Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Providence Health & Services
The Heart Institute of Spokane
Ochsner Health System
University of Washington
Principal Investigator: Katherine R. Tuttle, MD,FASN,FACP Providence Medical Research Center

Responsible Party: Katherine R. Tuttle, MD, Providence Medical Research Center
ClinicalTrials.gov Identifier: NCT00302627     History of Changes
Other Study ID Numbers: HI497
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: August 26, 2010
Last Verified: December 2002

Keywords provided by Providence Health & Services:
vitamin D
calcium supplement
corticosteroid therapy

Additional relevant MeSH terms:
Bone Diseases
Kidney Diseases
Musculoskeletal Diseases
Urologic Diseases
Vitamin D
Calcium, Dietary
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents