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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

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

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? No
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 start date: 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
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