Pamidronate, Vitamin D, and Calcium for the Bone Disease of Kidney and Heart Transplantation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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.
- 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 |
Inclusion Criteria:
- Kidney or heart transplant recipients
Exclusion Criteria:
- Hyperparathyroidism
Contacts and Locations| United States, Washington | |
| Providence Medical Research Center | |
| Spokane, Washington, United States, 99204 | |
| Principal Investigator: | Katherine R. Tuttle, MD,FASN,FACP | Providence Medical Research Center |
More Information
Additional 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 June 18, 2013