NCT00273260

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

May 9, 2006

Status Verified

January 1, 2006

First QC Date

January 5, 2006

Last Update Submit

May 8, 2006

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

Secondary Outcomes (4)

  • physical activity

  • dietary calcium intake

  • calcium supplement use

  • smoking status

Interventions

individualised bone density feedback and educationBEHAVIORAL

Eligibility Criteria

Age25 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women aged between 25 and 44 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menzies Research Institute

Hobart, Tasmania, 7000, Australia

Location

Related Publications (8)

  • 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.

    PMID: 16336993BACKGROUND

  • 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.

    PMID: 15722593RESULT

  • 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.

    PMID: 15674306RESULT

  • 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.

    PMID: 12877751RESULT

  • 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.

    PMID: 16430773RESULT

  • 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.

    PMID: 29246678DERIVED

  • 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.

    PMID: 27631092DERIVED

  • 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.

    PMID: 26919994DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Graeme Jones, MD

    Menzies Institute for Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

January 1, 2000

Study Completion

December 1, 2002

Last Updated

May 9, 2006

Record last verified: 2006-01

Locations

AU(1)