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

This study has been completed.
Sponsor:
Collaborators:
The Heart Institute of Spokane
Ochsner Health System
University of Washington
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00302627
First received: March 10, 2006
Last updated: August 25, 2010
Last verified: December 2002
  Purpose

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 Intervention
Transplant Bone Disease
Drug: Pamidronate
Drug: vitamin D
Drug: calcium supplement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pamidronate, Vitamin D, and Calcium for the Bone Disease of Kidney and Heart Transplantation

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Bone mineral density measured by dual-energy X-ray absorptiometry [ Time Frame: Every 12 months ] [ Designated as safety issue: No ]
    Performed at 1 year and 2 years.


Secondary Outcome Measures:
  • Fracture events [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    Evaluated at 6, 12, 18 months and 2 years

  • serum calcium [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    baseline, 6,12,18 months and 2 years

  • parathyroid hormone [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    baseline, 6,12,18 months and 2 years

  • serum creatinine and estimated glomerular filtration rate [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    Performed at 6,12,18 months and 2 years

  • proteinuria [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    Evaluated at 6,12,18 months and 2 years


Enrollment: 43
Study Start Date: January 1999
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kidney or heart transplant recipients

Exclusion Criteria:

  • Hyperparathyroidism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302627

Locations
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
Investigators
Principal Investigator: Katherine R. Tuttle, MD,FASN,FACP Providence Medical Research Center
  More Information

No publications provided

Responsible Party: Katherine R. Tuttle, MD, Providence Medical Research Center
ClinicalTrials.gov Identifier: NCT00302627     History of Changes
Other Study ID Numbers: HI497
Study First Received: March 10, 2006
Last Updated: August 25, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 14, 2014