NCT03280693

Brief Summary

Body composition, bone mineral density (BMD), and body balance are important factors that threaten postural control. They act as vital elements in the vicious circle that leads to fracture occurrence in elderly population, particularly postmenopausal women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

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

May 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

September 4, 2017

Last Update Submit

September 11, 2017

Conditions

OsteoporosisFall PatientsPostmenopausal Disorder

Keywords

Body mass index,Bone densityBalancePostmenopause

Outcome Measures

Primary Outcomes (2)

  • correlation between BMI and body balance

    correlation analysis between BMI and body balance

    7 months

  • correlation between BMI and BMD

    correlation analysis between BMI and BMD

    7 months

Interventions

Diagnostic testDIAGNOSTIC_TEST

Body balance was assessed using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan.

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is based on investigating changes in the measured variables in postmenopausal women
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Forty-eight postmenopausal women participated in this study. Their mean values of age, body mass, height, and BMI were 53.5 ± 2.75 y, 89.08 ± 12.3 Kg, 159.67.8 ± 2.54 cm, and 34.89 ± 4.89 Kg/m², respectively. Body balance was assessed using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan.

You may qualify if:

  • postmenopausal women with ages range from 50 to 60 years

You may not qualify if:

  • participation in sports
  • vertebrobasillar insufficiency
  • poor diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Liu-Ambrose T, Eng J, Khan K., Carter ND, McKay HA. Older women with osteoporosis have increased postural sway and weaker quadriceps strength than counterparts with normal bone mass: overlooked determinants of fracture risk? J Gerontol A Biol Sci Med Sci. 2003. 58 (9): 862-6. Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the timed up and go test. Phys Ther. 2000. 80(9): 896-903. Sinaki M, Brey RH, Hughes CA, Larson DR, Kaufman KR. Balance disorder and increased risk of falls in osteoporosis and kyphosis: significance of kyphotic posture and muscle strength. Osteoporos Int. 2005.16 (8):1004-10. Liu-Ambrose T, Eng JJ, Khan KM, Mallinson A, Carter ND, McKay HA. The influence of back pain on balance and functional mobility in 65 to 75 year old women with osteoporosis. Osteoporosis Int. 2002. 13 (11): 868-73. Lynn SG, Sinaki M, Westerlind KC. Balance characteristics of person with osteoporosis. Arch Phys Med Rehabil. 1997. 78 (3): 273-6. Frost HD. Wolff's law and bone's structural adaptations to mechanical usage: an overview for clinicians. The angle Orthod. 1994. 64 (3): 175-80. Taes YE, Lapauw B, Vanbillemont G, Bogaert V, De Bac¬quer D, Zmierczak H, et al. Fat mass is negatively associat¬ed with cortical bone size in young healthy male siblings. J Clin Endocrinol Metab. 2009; 94 (7): 2325-31.

    BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal invstigator

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 12, 2017

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share