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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00273260




Registration number
NCT00273260
Ethics application status
Date submitted
5/01/2006
Date registered
9/01/2006
Date last updated
9/05/2006

Titles & IDs
Public title
The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women
Scientific title
The Effect on Behavior and Bone Mineral Density of Individualized Bone Mineral Density Feedback and Educational Interventions in Premenopausal Women: a Randomized Controlled Trial.
Secondary ID [1] 0 0
MRI-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bone mineral density
Timepoint [1] 0 0
Secondary outcome [1] 0 0
physical activity
Timepoint [1] 0 0
Secondary outcome [2] 0 0
dietary calcium intake
Timepoint [2] 0 0
Secondary outcome [3] 0 0
calcium supplement use
Timepoint [3] 0 0
Secondary outcome [4] 0 0
smoking status
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
* women aged between 25 and 44 years of age
Minimum age
25 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* previous had measurement of bone densitometry
* thyroid disease
* renal failure
* malignancy
* rheumatoid arthritis
* history of hysterectomy
* hormone replacement therapy
* were pregnant or planning pregnancy within 2 years of study entry
* lactating.

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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2000
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)
TAS
Recruitment hospital [1] 0 0
Menzies Research Institute - Hobart
Recruitment postcode(s) [1] 0 0
7000 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies Institute for Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether giving women feedback concerning their bone mineral density, combined with either an information leaflet or group education concerning osteoporosis changes women's behavior and/or bone density.
Trial website
https://clinicaltrials.gov/study/NCT00273260
Trial related presentations / publications
Winzenberg TM, Oldenburg B, Frendin S, De Wit L, Jones G. A mother-based intervention trial for osteoporosis prevention in children. Prev Med. 2006 Jan;42(1):21-6. doi: 10.1016/j.ypmed.2005.11.006. Epub 2005 Dec 5.
Winzenberg TM, Oldenburg B, Frendin S, De Wit L, Jones G. Effects of bone density feedback and group education on osteoporosis knowledge and osteoporosis self-efficacy in premenopausal women: a randomized controlled trial. J Clin Densitom. 2005 Spring;8(1):95-103. doi: 10.1385/jcd:8:1:095.
Winzenberg TM, Riley M, Frendin S, Oldenburg B, Jones G. Sociodemographic factors associated with calcium intake in premenopausal women: a cross-sectional study. Eur J Clin Nutr. 2005 Mar;59(3):463-6. doi: 10.1038/sj.ejcn.1602105.
Winzenberg TM, Oldenburg B, Frendin S, Jones G. The design of a valid and reliable questionnaire to measure osteoporosis knowledge in women: the Osteoporosis Knowledge Assessment Tool (OKAT). BMC Musculoskelet Disord. 2003 Jul 24;4:17. doi: 10.1186/1471-2474-4-17.
Winzenberg T, Oldenburg B, Frendin S, De Wit L, Riley M, Jones G. The effect on behavior and bone mineral density of individualized bone mineral density feedback and educational interventions in premenopausal women: a randomized controlled trial [NCT00273260]. BMC Public Health. 2006 Jan 23;6:12. doi: 10.1186/1471-2458-6-12.
Wu F, Wills K, Laslett LL, Riley MD, Oldenburg B, Jones G, Winzenberg T. Individualized Fracture Risk Feedback and Long-term Benefits After 10 Years. Am J Prev Med. 2018 Feb;54(2):266-274. doi: 10.1016/j.amepre.2017.10.018. Epub 2017 Dec 13.
Wu F, Wills K, Laslett LL, Oldenburg B, Seibel MJ, Jones G, Winzenberg T. Cut-points for associations between vitamin D status and multiple musculoskeletal outcomes in middle-aged women. Osteoporos Int. 2017 Feb;28(2):505-515. doi: 10.1007/s00198-016-3754-9. Epub 2016 Sep 9.
Wu F, Callisaya M, Laslett LL, Wills K, Zhou Y, Jones G, Winzenberg T. Lower limb muscle strength is associated with poor balance in middle-aged women: linear and nonlinear analyses. Osteoporos Int. 2016 Jul;27(7):2241-2248. doi: 10.1007/s00198-016-3545-3. Epub 2016 Feb 26.
Public notes

Contacts
Principal investigator
Name 0 0
Graeme Jones, MD
Address 0 0
Menzies Institute for Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00273260