Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000900819
Ethics application status
Approved
Date submitted
17/08/2012
Date registered
24/08/2012
Date last updated
24/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing the needs of osteoporosis prevention in postmenopausal women attending a tertiary hospital in Malaysia
Scientific title
Addressing the needs of osteoporosis prevention in postmenopausal women attending a tertiary hospital in Malaysia via osteoporosis screening conducted by pharmacist to identify undiagnosed osteoporosis cases.
Secondary ID [1] 281053 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis prevention in postmenopausal women 287194 0
Condition category
Condition code
Musculoskeletal 287523 287523 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventional package:

At baseline:
a. One counselling session on the safe use of medications and lifestyle education.
(This will be an individual counselling session with a trained pharmacist which will take about 30 minutes)
b. Osteoporosis risk assessment using the tool Osteoporosis Screening Tool for Asians(OSTA).
(The osteoporosis risk of the patients will be assessed only at baseline by the pharmacist using the OSTA which utilizes a simple calculation using the age and weight of the patients. This will take about 5 minutes.)
c. Recommendation by pharmacist for Bone Mineral Density(BMD) scan as necessary.
d. Assessment of knowledge using the knowledge tool Osteoporosis Prevention Awareness Assessment Tool(OPAAT).
(OPAAT is a close ended questionaire that will be administered to the patients. This will take about 15 minutes.)
e. Recommendation by pharmacist for referral to the osteoporosis clinic as necessary.

First follow up phone (one month later):
a. Assessment of knowledge (OPAAT)
b. Assessment of satisfaction using the Satisfaction Questionaire for Osteoporosis Prevention(SQOP)
(SQOP is a close ended questionaire that will be administered to patient. This will take about 10 minutes)

Second follow up via phone(three months later):
To assess if patients attended the osteoporosis clinic
To assess if patients were started on osteoporosis medication
Intervention code [1] 285511 0
Early detection / Screening
Comparator / control treatment
Standard care refers to usual visit to the doctor with no routine osteoporosis screening services conducted
Control group
Active

Outcomes
Primary outcome [1] 287766 0
Number of patients diagnosed with osteoporosis/osteopenia
(self report and countercheck with medical record data)
Timepoint [1] 287766 0
At 6 months after randomisation
Primary outcome [2] 287767 0
Number of patients sent for BMD scan
(self report and countercheck with medical record data)
Timepoint [2] 287767 0
At day 1 of randomisation
Primary outcome [3] 287768 0
Health economic benefit
(medical record data and statistical calculations)
Timepoint [3] 287768 0
At 6 months of randomisaion
Secondary outcome [1] 298804 0
Patient satisfaction (SQOP)
Timepoint [1] 298804 0
At 1 month after randomisation
Secondary outcome [2] 298805 0
Knowledge of osteoporosis (OPAAT)
Timepoint [2] 298805 0
At 1 month after randomisation
Secondary outcome [3] 298806 0
Reasons why the BMD scan was not ordered although recommended
(open ended questionnaire)
Timepoint [3] 298806 0
At 1 month after randomisation

Eligibility
Key inclusion criteria
All post menopausal women above 50 years of age and who are able to converse in English
Minimum age
50 Years
Maximum age
100 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who were previously diagnosed with osteoporosis or refuse to participate in this study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 4490 0
Malaysia
State/province [1] 4490 0
Wilayah Persekutuan

Funding & Sponsors
Funding source category [1] 285837 0
Self funded/Unfunded
Name [1] 285837 0
Toh Li Shean
Country [1] 285837 0
Malaysia
Primary sponsor type
University
Name
University of Nottingham
Address
School of Pharmacy, Faculty of Science, University of Nottingham Malaysia Campus, Jalan Broga, 43500 Semenyih, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 284657 0
University
Name [1] 284657 0
University of Malaya
Address [1] 284657 0
Department of Primary Care Medicine, Faculty of Medicine Building, University of Malaya, 50603 Kuala Lumpur, MALAYSIA
Country [1] 284657 0
Malaysia
Secondary sponsor category [2] 284658 0
University
Name [2] 284658 0
University of Nottingham
Address [2] 284658 0
School of Pharmacy Building, University Park, University of Nottingham, Nottingham NG7 2RD, United Kingdom.
Country [2] 284658 0
United Kingdom

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Osteoporosis is a preventable disease that causes bone loss increasing the risk for fractures. The World Health Organization provides that the worldwide projection of hip fractures cases due to osteoporosis will raise from 1.7 million in 1990 to 6.3 million by 2050 with a steep increase to be observed in developing countries.The needs of patients with osteoporosis may not be addressed as this disease is usually asymptomatic in its early stages. Hence, women who may have osteoporosis remained unidentified leading to possible unwanted fractures. Fractures are complications of untreated osteoporosis incurring a considerable amount of cost, and an increase in probability of morbidity and mortality. Therefore, prevention measures and screening which aid in early detection are the most effective and cost-effective ways to reduce the number of hospital admittance due to osteoporotic fractures thereby ensuring patient safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34592 0
Address 34592 0
Country 34592 0
Phone 34592 0
Fax 34592 0
Email 34592 0
Contact person for public queries
Name 17839 0
TOH LI SHEAN
Address 17839 0
School of Pharmacy, Faculty of Science, University of Nottingham Malaysia Campus, Jalan Broga, 43500 Semenyih, Selangor, Malaysia.
Country 17839 0
Malaysia
Phone 17839 0
+60122846849
Fax 17839 0
Email 17839 0
[email protected]
Contact person for scientific queries
Name 8767 0
TOH LI SHEAN
Address 8767 0
School of Pharmacy, Faculty of Science, University of Nottingham Malaysia Campus, Jalan Broga, 43500 Semenyih, Selangor, Malaysia.
Country 8767 0
Malaysia
Phone 8767 0
+60122846849
Fax 8767 0
Email 8767 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
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