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Completed

NCT Number: NCT00302627

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence Medical Research Center

Spokane, Washington, 99204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Kidney or heart transplant recipients

Exclusion criteria

  • Hyperparathyroidism

Treatment and study plan

Pamidronate

Drug

60mg or 90mg given at baseline, 6,12,18, and 24 months

Other names: Transplant Bone Disease

Vitamin D

Drug

baseline, 6,12 months

Other names: Vitamin D administration in Transplant

Calcium Carbonate

Drug

baseline, 6,12 months

Other names: Calcium administration in Transplant

Primary outcomes

  1. Bone mineral density measured by dual-energy X-ray absorptiometry

    Time frame: Every 12 months

    Performed at 1 year and 2 years.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Providence Health & Services

Other

Collaborators

  • Ochsner Health System
  • The Heart Institute of Spokane
  • University of Washington

Registry information

Important dates

Study start
1999
Primary completion
2002
Study completion
2002
First posted
Mar 14, 2006
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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