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

Sponsor

Providence Health & Services (Other)

Overall Status

Completed

CT.gov ID

NCT00302627

Collaborator

The Heart Institute of Spokane (Other), Ochsner Health System (Other), University of Washington (Other)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Transplant Bone Disease	Drug: Pamidronate Drug: vitamin D Drug: Calcium Carbonate	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

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 :

Jan 1, 1999

Actual Primary Completion Date :

Nov 1, 2002

Actual Study Completion Date :

Nov 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pamidronate, Vitamin D, and Calcium 60mg or 90mg given at baseline, 6,12,18, and 24 months vitamin D 800 units/day calcium carbonate 1500 milligrams/day	Drug: Pamidronate 60mg or 90mg given at baseline, 6,12,18, and 24 months Other Names: Transplant Bone Disease Drug: vitamin D baseline, 6,12 months Other Names: Vitamin D administration in Transplant Drug: Calcium Carbonate baseline, 6,12 months Other Names: Calcium administration in Transplant

Arm

Intervention/Treatment

Experimental: Pamidronate, Vitamin D, and Calcium

60mg or 90mg given at baseline, 6,12,18, and 24 months vitamin D 800 units/day calcium carbonate 1500 milligrams/day

Drug: Pamidronate

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

Other Names:

Transplant Bone Disease

Drug: vitamin D

baseline, 6,12 months

Other Names:

Vitamin D administration in Transplant

Drug: Calcium Carbonate

baseline, 6,12 months

Other Names:

Calcium administration in Transplant

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Fracture events [Every 6 months]
Evaluated at 6, 12, 18 months and 2 years
serum calcium [Every 6 months]
baseline, 6,12,18 months and 2 years
parathyroid hormone [Every 6 months]
baseline, 6,12,18 months and 2 years
serum creatinine and estimated glomerular filtration rate [Every 6 months]
Performed at 6,12,18 months and 2 years
proteinuria [Every 6 months]
Evaluated at 6,12,18 months and 2 years