ANZCTR - Registration

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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.

Hyperparathyroidism in renal transplant recipients.

Condition category

Condition code

Renal and Urogenital

Kidney disease

Metabolic and Endocrine

Metabolic disorders

Musculoskeletal

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]

Treatment: Drugs

Comparator / control treatment

This is an uncontrolled study.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

After 7 days of calcium citrate.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Queen Elizabeth Hospital Renal Unit

Address [1]

28 Woodville Road
Woodville South
SA 5011

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics of Human Research Committee (TQEH & LMH)

Ethics committee address [1]

The Queen Elizabeth Hospital 
28 Woodville Road
Woodville South SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/02/2009

Approval date [1]

06/05/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Raymond Yu

Address

Basil Hetzel Institute
28 Woodville Road
Woodville South
SA 5011

Country

Australia

Phone

+61 403 414 162

Fax

raymond.yu@student.adelaide.edu.au

Contact person for scientific queries

Name

Raymond Yu

Address

Basil Hetzel Institute
28 Woodville Road
Woodville South
SA 5011

Country

Australia

Phone

+61 403 414 162

Fax

raymond.yu@student.adelaide.edu.au

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.

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