Transplant Bone DiseaseNCT00302627
Pamidronate, Vitamin D, and Calcium for the Bone Disease of Kidney and Heart Transplantation
A study testing Pamidronate, vitamin D and Calcium Carbonate in people with Transplant Bone Disease, run by Providence Health & Services at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Bone Disease
- What is being tested?
- Pamidronate, vitamin D and Calcium Carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Nov 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney or heart transplant recipients
Who cannot join
- Hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Medical Research Center
Spokane, Washington, 99204
About this study
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.
Read the 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.
- Conditions
- Transplant Bone Disease
- Being tested
- Pamidronate, vitamin D, Calcium Carbonate
- Keywords
- bisphosphonates, vitamin D, calcium supplement, corticosteroid therapy, fractures
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamidronateDrug
Also called Transplant Bone Disease
60mg or 90mg given at baseline, 6,12,18, and 24 months
vitamin DDrug
Also called Vitamin D administration in Transplant
baseline, 6,12 months
Calcium CarbonateDrug
Also called Calcium administration in Transplant
baseline, 6,12 months
| Study group | Role | What they receive |
|---|---|---|
| Pamidronate, Vitamin D, and Calcium | Experimental | 60mg or 90mg given at baseline, 6,12,18, and 24 months
vitamin D 800 units/day
calcium carbonate 1500 milligrams/day Receives: Drug: Pamidronate; Drug: vitamin D; Drug: Calcium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density measured by dual-energy X-ray absorptiometry
Performed at 1 year and 2 years.
Measured: Every 12 months
Secondary outcomes (5)
Fracture events
Evaluated at 6, 12, 18 months and 2 years
Measured: Every 6 months
serum calcium
baseline, 6,12,18 months and 2 years
Measured: Every 6 months
parathyroid hormone
baseline, 6,12,18 months and 2 years
Measured: Every 6 months
serum creatinine and estimated glomerular filtration rate
Performed at 6,12,18 months and 2 years
Measured: Every 6 months
proteinuria
Evaluated at 6,12,18 months and 2 years
Measured: Every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJan 1999
- Primary completionNov 2002
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Bone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- The Heart Institute of Spokane, Ochsner Health System, University of Washington
- Responsible party
- Sponsor
- Investigators
- Katherine R. Tuttle, MD,FASN,FACP, Principal investigator, Providence Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302627
- Sponsor's protocol ID
- HI497
- Status last verified
- Aug 2018
- First submitted
- 10 Mar 2006
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pamidronate, Vitamin D, and Calcium for the Bone Disease of Kidney and Heart Transplantation
- ClinicalTrials.gov ID
- NCT00302627
- Acronym / sponsor ID
- HI497
- Conditions
- Transplant Bone Disease
- Keywords
- bisphosphonates, vitamin D, calcium supplement, corticosteroid therapy, fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- The Heart Institute of Spokane, Ochsner Health System, University of Washington
- Study start
- Jan 1999
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pamidronate, Vitamin D, and Calcium | Experimental | Drug: Pamidronate, Drug: vitamin D, Drug: Calcium Carbonate60mg or 90mg given at baseline, 6,12,18, and 24 months vitamin D 800 units/day calcium carbonate 1500 milligrams/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney or heart transplant recipients
Key exclusion criteria (1 listed)
- Hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PamidronateAlso: Transplant Bone Disease60mg or 90mg given at baseline, 6,12,18, and 24 months | Drug | Pamidronate, Vitamin D, and Calcium |
| vitamin DAlso: Vitamin D administration in Transplantbaseline, 6,12 months | Drug | Pamidronate, Vitamin D, and Calcium |
| Calcium CarbonateAlso: Calcium administration in Transplantbaseline, 6,12 months | Drug | Pamidronate, Vitamin D, and Calcium |
Primary outcome
Bone mineral density measured by dual-energy X-ray absorptiometry
Time frame: Every 12 months
Performed at 1 year and 2 years.
5 secondary outcomes
Fracture events
Time frame: Every 6 months
serum calcium
Time frame: Every 6 months
parathyroid hormone
Time frame: Every 6 months
serum creatinine and estimated glomerular filtration rate
Time frame: Every 6 months
proteinuria
Time frame: Every 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Related trials for Transplant Bone Disease
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RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
RecruitingObservational study
HPC Offered for PRESERVE Expansion
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RecruitingPhase 2
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine R. Tuttle, MD,FASN,FACP principal investigator
Providence Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pamidronate, vitamin D and Calcium Carbonate in people with Transplant Bone Disease, run by Providence Health & Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density measured by dual-energy X-ray absorptiometry (time frame: Every 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.