ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

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

Condition category

Condition code

Musculoskeletal

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]

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]

Compliance with osteoporosis medication

Timepoint [1]

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]

Complications from osteoporosis therapy

Timepoint [2]

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]

Changes in life style

Timepoint [3]

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]

Incident clinical fracture

Timepoint [1]

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]

Changes in bone mineral density

Timepoint [2]

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]

Changes in bone metabolism

Timepoint [3]

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

Sex

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

1/04/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

250

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Endocrinology and Metabolism, Concord Repatriation Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Department of Endocrinology and Metabolism, Concord Repatriation Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SSWAHS Human Research Ethics Committee - Concord Repatriation General Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/12/2005

Ethics approval number [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Dr Paul Lee

Address

Department of Endocrinology and Metabolism
Concord Hospital
Level 6
Medical Centre
Concord NSW 2139

Country

Australia

Phone

+61 2 97676747

Fax

+61 2 97677472

Email

[email protected]

Contact person for scientific queries

Name

Dr Paul Lee

Address

Department of Endocrinology and Metabolism
Concord Hospital
Level 6
Medical Centre
Concord NSW 2139

Country

Australia

Phone

+61 2 97676747

Fax

+61 2 97677472

Email

[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

Source	Title	Year of Publication	DOI
Embase	Targeted intervention reduces refracture rates in patients with incident non-vertebral osteoporotic fractures: A 4-year prospective controlled study.	2011	https://dx.doi.org/10.1007/s00198-010-1477-x

N.B. These documents automatically identified may not have been verified by the study sponsor.