Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000250235
Ethics application status
Approved
Date submitted
25/02/2009
Date registered
12/05/2009
Date last updated
30/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Calcium supplementation and its effect on bone loss in renal transplant recipients.
Scientific title
Calcium citrate and its effects on bone loss and hyperparathyroidism in renal transplant recipients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone loss in renal transplant recipients. 4749 0
Hyperparathyroidism in renal transplant recipients. 4750 0
Condition category
Condition code
Renal and Urogenital 4628 4628 0 0
Kidney disease
Metabolic and Endocrine 237085 237085 0 0
Metabolic disorders
Musculoskeletal 237086 237086 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Calcium citrate, oral, 500mg (2 tablets) every night for 7 days.
Intervention code [1] 4113 0
Treatment: Drugs
Comparator / control treatment
This is an uncontrolled study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5498 0
Parathyroid hormone level obtained via standard IMVS protocol. 10ml blood sample taken in the morning with patient fasted overnight. Blood samples are sent to IMVS (Institute of Medical and Veterinary Sciences) laboratory at The Queen Elizabeth Hospital, Woodville SA and analysed.
Timepoint [1] 5498 0
After 7 days of calcium citrate.
Secondary outcome [1] 9260 0
Biochemical markers of calcium metabolism and bone turnover - serum calcium, serum phosphate, alkaline phosphatase, osteocalcin, C-telopeptide crosslaps. These biochemical markers will be obtained and measured using the standard IMVS protocol. 10ml blood sample taken in the morning with patient fasted overnight. Blood sample will be sent to IMVS laboratory at The Queen Elizabeth Hospital, Woodville SA and analysed.
Timepoint [1] 9260 0
After 7 days of calcium citrate.

Eligibility
Key inclusion criteria
Previous renal transplant over 1 year ago.
Stable renal function (Creatinine < 150) Standard immunosuppression regime (Tacrolimus, Mycophenolate Mofetil and Prednisolone).
Able to give informed consent.
Able to attend 3 sessions held over 1 week.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Preexisting hypercalcemia (Ca > 2.55 mmol/L), severe hyperparathyroidism (PTH > 50 pmol/L) or severe vitamin D insufficiency (serum 25-hydoxy vitamin D < 15 ng/mL).
Previous parathyroidectomy.
Concurrent use of bisphosphonates, Vitamin D analogues, lithium, phenytoin, carbamazepine, hormone replacement therapy, thiazide diuretics.
Participation in a concurrent study.
Pre-menopausal women (due to low level radiation exposure).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4556 0
Hospital
Name [1] 4556 0
The Queen Elizabeth Hospital Renal Unit
Country [1] 4556 0
Australia
Primary sponsor type
Individual
Name
Dr Patrick T Coates
Address
The Queen Elizabeth Hospital Renal Unit,
28 Woodville Road
Woodville South
SA 5011
Country
Australia
Secondary sponsor category [1] 4112 0
None
Name [1] 4112 0
Address [1] 4112 0
Country [1] 4112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7011 0
Ethics of Human Research Committee (TQEH & LMH)
Ethics committee address [1] 7011 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 7011 0
Australia
Date submitted for ethics approval [1] 7011 0
24/02/2009
Approval date [1] 7011 0
06/05/2009
Ethics approval number [1] 7011 0
2009044

Summary
Brief summary
Today, there are approximately 800 patients with kidney transplants at the Royal Adelaide Hospital and The Queen Elizabeth Hospital combined. Bone density decreases both before and after transplantation. Fracture prevalence after kidney transplant is between 7 and 60%, with fracture risk up to four times higher in this group when compared with the normal population.

Potential causes for low bone density and an increased rate of bone loss are:

Hyperparathyroidism (overactive parathyroid glands). This can occur as a consequence of poor vitamin D levels. If this persists, the parathyroid glands may become permanently overactive leading to elevated parathyroid hormone (PTH) levels.

Poor calcium absorption from the gut.

Low Vitamin D levels.

Drugs which prevent transplant rejection, particularly prednisolone.

Hyperparathyroidism is of particular interest in this study, as it is a common finding in patients after kidney transplant. In these patients it has been associated with increased rates of bone loss as measured by markers of bone turnover and decreased bone mineral density.

Moreover it is well established that in healthy elderly adults, increased markers of bone turnover is a risk factor for fractures.

Postmenopausal women are known to have an increased rate of bone loss and have a mildly increased PTH level compared to premenopausal women. Previous studies showed that an oral calcium supplement reduced hyperparathyroidism and bone loss in this group.

Based on these findings in postmenopausal women, and the need for better evidence based management of bone disease in kidney transplant patients, we will study the effect of an oral calcium supplement in patients with kidney transplants. We predict that supplemental calcium will be a simple, well-tolerated and safe treatment to help maintain bone health in these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29322 0
Address 29322 0
Country 29322 0
Phone 29322 0
Fax 29322 0
Email 29322 0
Contact person for public queries
Name 12569 0
Raymond Yu
Address 12569 0
Basil Hetzel Institute
28 Woodville Road
Woodville South
SA 5011
Country 12569 0
Australia
Phone 12569 0
+61 403 414 162
Fax 12569 0
Email 12569 0
[email protected]
Contact person for scientific queries
Name 3497 0
Raymond Yu
Address 3497 0
Basil Hetzel Institute
28 Woodville Road
Woodville South
SA 5011
Country 3497 0
Australia
Phone 3497 0
+61 403 414 162
Fax 3497 0
Email 3497 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.