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

Transplant Bone Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302627
• Other study ID #: HI497
• Status: Completed
• Phase: N/A
• Start date: January 1999
• Est. completion date: November 2002

Study information

• Verified date: August 2018
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2002
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Kidney or heart transplant recipients

Exclusion Criteria:

• Hyperparathyroidism

Related Conditions & MeSH terms

• Bone Diseases
• Kidney Diseases
• Transplant Bone Disease

Intervention

Drug:
• Pamidronate
60mg or 90mg given at baseline, 6,12,18, and 24 months
• vitamin D
baseline, 6,12 months
• Calcium Carbonate
baseline, 6,12 months

Locations

Country	Name	City	State
United States	Providence Medical Research Center	Spokane	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Providence Health & Services	Ochsner Health System, The Heart Institute of Spokane, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density measured by dual-energy X-ray absorptiometry	Performed at 1 year and 2 years.	Every 12 months
Secondary	Fracture events	Evaluated at 6, 12, 18 months and 2 years	Every 6 months
Secondary	serum calcium	baseline, 6,12,18 months and 2 years	Every 6 months
Secondary	parathyroid hormone	baseline, 6,12,18 months and 2 years	Every 6 months
Secondary	serum creatinine and estimated glomerular filtration rate	Performed at 6,12,18 months and 2 years	Every 6 months
Secondary	proteinuria	Evaluated at 6,12,18 months and 2 years	Every 6 months