Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

000349

ACTR Number:

ACTRN12605000274673

Trial Status:

Registered

Date Submitted:

1/09/2005

Date Registered:

2/09/2005

Page 1

Public title:

The effect of calcium supplementation on lipids and bone density in men.

ANZCTR registration title:

The effect of calcium supplementation on serum lipids and bone density in normal men.

Secondary ID:

UTN:

Trial acronym:

Page 2
Health condition(s) or problem(s) studied:
Normal men

Other	Other alternative and complementary medicine
Condition category:	Condition code:

Page 3

Description of intervention(s) / exposure:

Daily 600mg calcium (as the citrate) or 1200mg calcium (as the citrate) over 2 years.

Intervention code:

Prevention

Comparator / control treatment:

Placebo

Control group:

Placebo

Page 4
Primary outcome:	The difference between the ratio of HDL/LDL cholesterol over 2 years in three treatment groups.
Timepoint:
Secondary outcome 1:	The difference between changes in LDL cholesterol, HDL cholesterol, total cholesterol, HDL/total cholesterol ratio, triglycerides.
Timepoint:	Over 2 years in the three treatment groups.
Secondary outcome 2:	The difference between changes in spine, hip and total body bone mineral density, blood pressure, soft tissue mass and its distribution.
Timepoint:	Over 2 years in the three treatment groups.

Page 5

Key inclusion criteria:

Males, Age > 40 years, Life expectancy > 5 years.

Minimum Age:

40 Years

Maximum Age:

Not stated

Gender:

Males

Healthy volunteers?

Key exclusion criteria:

Coronary heart disease, Diabetes, 5 yr predicted cardiovascular risk of > 15%, Renal impairment (serum creatinine > 0.2mmol/l), Untreated hypo- or hyperthyroidism Active liver disease Serum 25-hydroxyvitamin D < 25 nmol/l Concurrent major systemic disease, including malignancy, Metabolic bone disease, Current treatment for hyperlipidaemia or osteoporosis, Regular use of testosterone replacement therapy within the previous 1 year, Regular use of anabolic steroid preparations in the previous 1 year, Treatment with bisphosphonates in the previous 1 year, Treatment with glucocorticoid drugs in the previous year, Lumbar spine bone density < mean-2.0 SD for age-appropriate data (ie: Z score < -2).

Page 6

Study type:

Interventional

Purpose of the study:

Prevention

Allocation to intervention:

Randomised controlled trial

Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):

Subject numbers allocated by personnel based in a different building and having no contact with study subjects

Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):

Computer-generated random numbers in variable blocks

Masking / blinding:

Blinded (masking used)

Who is/are masked/blinded:

Assignment:

Parallel

Other design features (specify):

Type of endpoint(s):

Efficacy

Page 7

Phase

Phase 4

Anticipated or actual date of first participant enrolement:

1/07/2003

Target sample size:

300

Recruitment status:

Closed: follow-up continuing

Page 8

Funding source:

Government funding body e.g. Australian Research Council

Name:

Health Research Council of New Zealand

Address:

Country:

New Zealand

Primary sponsor:

Individual

Name:

Professor I Reid

Address:

Country:

Secondary sponsor:

University

Name:

University of Auckland Bone Research Group

Address:

Country:

New Zealand

Other collaborator:

Page 9

Has the study received approval from at least one ethics committee?

Yes

Ethics Committee name:

Auckland University

Address:

Country:

Australia

Date of approval:

HREC Number:

Countries of recruitment:

Outside Australia

New Zealand

Brief summary:

This is a 2 year study designed to determine the effect 1g of calcium supplements daily on lipids and bone density in men.

Trial website:

Presentations / publication list:

Page 10

Contact person for public queries

Name:

Ruth Ames

Address:

Bone Research Group Department of Medicine Auckland University Private Bag 92 019 Auckland 1020

Country:

New Zealand

Tel:

+64 9 3078970

Fax:

+64 9 3737677

Email:

osteo@auckland.ac.nz

Contact person for scientific queries

Name:

Professor Reid

Address:

Bone Research Group Department of Medicine Auckland University Private Bag 92 019 Auckland 1020

Country:

New Zealand

Tel:

+64 9 3737599

Fax:

+64 9 3737677

Email:

i.reid@auckland.ac.nz

Contact person responsible for updating information

Name:

Address:

Country:

Tel:

Fax:

Email:

Trial Details

Page 1

Page 2

Page 3

Page 4

Page 5

Page 6

Page 7

Page 8

Page 9

Page 10