Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000381381
Ethics application status
Approved
Date submitted
22/07/2008
Date registered
1/08/2008
Date last updated
1/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing bioequivalence of oral cholecalciferol and ergocalciferol treatment for 3 months in Australian hip fracture cases
Scientific title
A three month prospective study of elderly australian hip fracture patients treated with ergocalciferol compared with cholecalciferol therapy: The vitamin D outcome study
Universal Trial Number (UTN)
Trial acronym
VDOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 3441 0
Hip fractures 3472 0
Condition category
Condition code
Musculoskeletal 3634 3634 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ergocalciferol 1000 IU daily oral therapy plus matching placebo (sugar pills) daily and taken at the same time for 3 months
Intervention code [1] 3203 0
Treatment: Other
Comparator / control treatment
Cholecalciferol 1000 IU daily oral therapy plus matching oral placebo (sugar capsule) daily and taken at the same time for 3 months
Control group
Active

Outcomes
Primary outcome [1] 4531 0
Increase in 25 hydroxyvitamin D as measured by high performance liquid chromatography
Timepoint [1] 4531 0
Single measurement at baseline and on completion of 3 months study
Secondary outcome [1] 7607 0
Increase in 1,25 dihydroxyvitamin D as measured by radioimmunoassay
Timepoint [1] 7607 0
Single measurement at baseline and on completion of 3 months study
Secondary outcome [2] 7661 0
Increase in 25-hydroxyvitamin D as measured by radioimmunoassay
Timepoint [2] 7661 0
Single measurement at baseline and on completion of 3 months study
Secondary outcome [3] 7662 0
Change in parathyroid hormone
Timepoint [3] 7662 0
Single measurement at baseline and on completion of 3 months study
Secondary outcome [4] 7663 0
Change in vitamin D binding protein
Timepoint [4] 7663 0
Single measurement at baseline and on completion of 3 months study
Secondary outcome [5] 7665 0
Increase in 25 OHD as measured by diasorin Radioimunoassay
Timepoint [5] 7665 0
Single measurement at baseline and on completion of 3 months study

Eligibility
Key inclusion criteria
Hip fracture
Residing in Perth metropolitan area
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ionised hypercalcemia
History of thyrotoxicosis/Cushings in last 2 years
Anticonvulsant medication use
Current or within last 3 months use of estrogen, raloxifene, calcitriol, anabolic steroids, bisphosphonates, sodium fluoride or corticosteroids
Renal failre as defined by serum creatinine > 150 umol/L
Patients unlikely to comply or live longer than 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Block randomistation of eligible patients by RPH pharmacy. Allocation concealment was attained by using numbered containers, central randomisation by phone/fax at RPH pharmacy by a pharmacist who was not otherwise involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Maching placebo tablets used to ensure patients and researchers are blinded to treatment assignment.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/09/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3655 0
Hospital
Name [1] 3655 0
Medical Research Foundation
Country [1] 3655 0
Australia
Primary sponsor type
Hospital
Name
Medical Research Foundation
Address
Royal Perth Hospital
Wellington Street
Perth 6000
Country
Australia
Secondary sponsor category [1] 3282 0
None
Name [1] 3282 0
Address [1] 3282 0
Country [1] 3282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5707 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 5707 0
Box X2213
GPO Perth 6847
Ethics committee country [1] 5707 0
Australia
Date submitted for ethics approval [1] 5707 0
Approval date [1] 5707 0
12/03/2002
Ethics approval number [1] 5707 0

Summary
Brief summary
Approximately 100 hip fracture cases are expected to be recruited over a 12 month period who are vitamin D insufficient, reside in the Perth metropolitan area, consent to inclusion in the trial and don’t fulfill any exclusion citeria. Vitamin D insufficiency will be defined as a 25 OHD < 50 nmol/L and initially measured using our current assay (Diasorin 25OHD radioimmunoassay). In a randomised fashion all vitamin D insufficient patients will be offered standard therapy with Ostelin 1000 I.U./day (ergocalciferol) or Vigantoletten 1000 I.U./day (Cholecalciferol obtained from Merck, Germany) in addition to matching placebo to prevent unblinding of study design. Those patients consenting to trial entry will have serum collected for intact PTH, whole PTH, ionised calcium, vitamin D binding protein and 1,25 dihydroxyvitamin D at baseline and following three months therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28771 0
Address 28771 0
Country 28771 0
Phone 28771 0
Fax 28771 0
Email 28771 0
Contact person for public queries
Name 11928 0
Dr Paul Glendenning
Address 11928 0
Department of Core CLinical Pathology and Biochemistry
Royal Perth Hospital
Wellington Street
Perth 6000
Country 11928 0
Australia
Phone 11928 0
08 9224 2421
Fax 11928 0
Email 11928 0
[email protected]
Contact person for scientific queries
Name 2856 0
Dr Paul Glendenning
Address 2856 0
Royal Perth Hospital
Wellington Street
Perth 6000
Country 2856 0
Australia
Phone 2856 0
08 9224 2421
Fax 2856 0
Email 2856 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.