search
Back to results

The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
individualised bone density feedback and education
Sponsored by
Menzies Institute for Medical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

25 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: women aged between 25 and 44 years of age 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.

Sites / Locations

  • Menzies Research Institute

Outcomes

Primary Outcome Measures

Bone mineral density

Secondary Outcome Measures

physical activity
dietary calcium intake
calcium supplement use
smoking status

Full Information

First Posted
January 5, 2006
Last Updated
May 8, 2006
Sponsor
Menzies Institute for Medical Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00273260
Brief Title
The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Menzies Institute for Medical Research

4. Oversight

5. Study Description

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.
Detailed Description
Fractures due to osteoporosis are a major public health problem. Bone density is one of the major predictors of these osteoporotic fractures and is the result of the amount of bone gained in early life (i.e peak bone mass) and subsequent bone loss. Cigarette smoking, physical inactivity and inadequate calcium intake are widely regarded as risk factors for osteoporosis (as well as for other common diseases for the former two). Despite this information being widely available and actively promoted, the prevalence of these risk factors in the population remains unacceptably high. In women (mean age 33) taking part in a study of the determinants of bone mass in children, we recently reported substantial change in these behaviours at 12 months follow-up when women received an information leaflet and individualised bone density feedback. These women were highly selected and it is unclear if this response is representative of all women. With this study, we aim to test whether individualised bone density feedback, combined with either an information leaflet or small group education will change women's osteporosis preventive behaviors and/or bone density. Specifically, we aimed to test the following hypotheses: Women are more likely to change calcium intake and physical activity if their BMD is low. Group education (in the form of the Osteoporosis Prevention and Self Management course) will be more efficacious at changing these lifestyle behaviours than an information leaflet alone. Bone density feedback and educational intervention have independent effects on behavior and BMD change. Women who improve their physical activity or dietary calcium intake will have a change in bone mass over 2 years that is 0.34-0.54% per annum better (depending on site and lifestyle factor) than those who do not alter their behaviour.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
individualised bone density feedback and education
Primary Outcome Measure Information:
Title
Bone mineral density
Secondary Outcome Measure Information:
Title
physical activity
Title
dietary calcium intake
Title
calcium supplement use
Title
smoking status

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women aged between 25 and 44 years of age 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme Jones, MD
Organizational Affiliation
Menzies Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menzies Research Institute
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16336993
Citation
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.
Results Reference
background
PubMed Identifier
15722593
Citation
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.
Results Reference
result
PubMed Identifier
15674306
Citation
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.
Results Reference
result
PubMed Identifier
12877751
Citation
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.
Results Reference
result
PubMed Identifier
16430773
Citation
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.
Results Reference
result
PubMed Identifier
29246678
Citation
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.
Results Reference
derived
PubMed Identifier
27631092
Citation
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.
Results Reference
derived
PubMed Identifier
26919994
Citation
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.
Results Reference
derived

Learn more about this trial

The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women

We'll reach out to this number within 24 hrs