Clinical trial NCT00273260: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Menzies Institute for Medical Research
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

1. Women are more likely to change calcium intake and physical activity if their BMD is low.
2. 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.
3. Bone density feedback and educational intervention have independent effects on behavior and BMD change.
4. 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.

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.

Primary outcomes:
measure: Bone mineral density
Secondary outcomes:
measure: physical activity
measure: dietary calcium intake
measure: calcium supplement use
measure: smoking status
Other outcomes:
Locations:
city: Hobart
country: Australia
facility: Menzies Research Institute
state: Tasmania
Study officials:
affiliation: Menzies Institute for Medical Research
name: Graeme Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.