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Trial registered on ANZCTR


Trial ID
ACTRN12606000108516
Ethics application status
Approved
Date submitted
21/03/2006
Date registered
23/03/2006
Date last updated
23/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of Biannual followup at a specialist Endocrinology Clinic to manage osteoporosis through medication and lifestyle modification on compliance with medication, incidence of fractures and changes in bone mineral metabolism, in Patients Presenting to Hospital with a Minimal Trauma Fracture
Scientific title
The impact of Biannual followup at a specialist Endocrinology Clinic to manage osteoporosis through medication and lifestyle modification on compliance with medication, incidence of fractures and changes in bone mineral metabolism, in Patients Presenting to Hospital with a Minimal Trauma Fracture
Universal Trial Number (UTN)
Trial acronym
MTFS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 1073 0
Condition category
Condition code
Musculoskeletal 1153 1153 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(Group A) Biannual followup at a specialist Endocrinology Clinic comprising review of complicance with medication, complications from osteopososis therapy, incidenct clinical fractures, changes in bone mineral density and biochemical markers in bone metabolism. All patients will be assessed during a final review 2 years after their initial presentation, which follows the same pattern for the initial visit.
Intervention code [1] 947 0
Treatment: Other
Comparator / control treatment
The control group (Group B) shall be managed by GP and finally reviewed in specialist Endocrinology Clinic after 2 years.
Control group
Active

Outcomes
Primary outcome [1] 1549 0
Compliance with osteoporosis medication
Timepoint [1] 1549 0
These data shall be entered and kept in a dedicated data base for final analysis made at the end of the 2 year.
Primary outcome [2] 1550 0
Complications from osteoporosis therapy
Timepoint [2] 1550 0
These data shall be entered and kept in a dedicated data base for final analysis made at the end of the 2 year.
Primary outcome [3] 1551 0
Changes in life style
Timepoint [3] 1551 0
These data shall be entered and kept in a dedicated data base for final analysis made at the end of the 2 year.
Secondary outcome [1] 2795 0
Incident clinical fracture
Timepoint [1] 2795 0
These data shall be entered and kept in a dedicated data base for final analysis made at the end of the 2 year.
Secondary outcome [2] 2796 0
Changes in bone mineral density
Timepoint [2] 2796 0
These data shall be entered and kept in a dedicated data base for final analysis made at the end of the 2 year.
Secondary outcome [3] 2797 0
Changes in bone metabolism
Timepoint [3] 2797 0
These data shall be entered and kept in a dedicated data base for final analysis made at the end of the 2 year.

Eligibility
Key inclusion criteria
Symptomatic fracture (presenting with pain or impaired mobility); fracture resulted from minimal trauma, defined as a fall from standing height or any milder insult; expected to remain ambulatory throughout the entire study; expected to return for follow-up visits; able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study.
Minimum age
45 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Traumatic fracture, defined as a fall from more than standing height or any higher impact insult; asymptomatic fracture; history or presence of metastatic or myeloma bone disease/pathological fracture; patient represents an unacceptable medical or psychiatric risk for inclusion into the study.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
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] 1259 0
Hospital
Name [1] 1259 0
Department of Endocrinology and Metabolism, Concord Repatriation Hospital
Address [1] 1259 0
Country [1] 1259 0
Australia
Primary sponsor type
Hospital
Name
Department of Endocrinology and Metabolism, Concord Repatriation Hospital
Address
Country
Australia
Secondary sponsor category [1] 1116 0
None
Name [1] 1116 0
Nil
Address [1] 1116 0
Country [1] 1116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2594 0
SSWAHS Human Research Ethics Committee - Concord Repatriation General Hospital
Ethics committee address [1] 2594 0
Ethics committee country [1] 2594 0
Australia
Date submitted for ethics approval [1] 2594 0
Approval date [1] 2594 0
20/12/2005
Ethics approval number [1] 2594 0
CH62/6/2004-099

Summary
Brief summary
A prospective study to screen for osteoporosis in all patients presenting to Concord Hospital with a minimal trauma fracture, and to initiate appropriate treatment in osteoporotic patients. The aim is to assess, in a randomised study, the efficacy of semi-annual specialist reviews vs. GP follow-up in terms of compliance and osteoporosis complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35130 0
Address 35130 0
Country 35130 0
Phone 35130 0
Fax 35130 0
Email 35130 0
Contact person for public queries
Name 10136 0
Dr Paul Lee
Address 10136 0
Department of Endocrinology and Metabolism
Concord Hospital
Level 6
Medical Centre
Concord NSW 2139
Country 10136 0
Australia
Phone 10136 0
+61 2 97676747
Fax 10136 0
+61 2 97677472
Email 10136 0
paul.lee@email.cs.nsw.gov.au
Contact person for scientific queries
Name 1064 0
Dr Paul Lee
Address 1064 0
Department of Endocrinology and Metabolism
Concord Hospital
Level 6
Medical Centre
Concord NSW 2139
Country 1064 0
Australia
Phone 1064 0
+61 2 97676747
Fax 1064 0
+61 2 97677472
Email 1064 0
paul.lee@email.cs.nsw.gov.au