Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women

The incidence of osteoporosis has been increasing, as have fractures resulting from falls.

Study Overview

• Status: Completed
• Conditions: Postural Balance
• Intervention / Treatment: Other: Biomechanical analysis; Other: Kiphosis analysis; Other: Vitamin D level

Detailed Description

The overall objective of this study is to evaluate bipodal postural balance in postmenopausal women with and without lumbar osteoporosis. The specific objective is to determine the relationship between the degree of thoracic kyphosis and dosing of 25 OH vitamin D with postural balance in postmenopausal women with lumbar osteoporosis.

One hundred and twenty-six postmenopausal women between 55-65 years of age were evaluated and separated into two groups according to the bone mineral density values of their lumbar spine: the osteoporosis group and the control group.

Functional mobility was evaluated through the Timed Up and Go Test. Postural balance was evaluated using a AccuSway® model portable force platform, in standard standing position, with eyes open and closed, for 60". Data were collected, stored, and processed by the Balance Clinic® program, configured to 100 Hz frequency, with a frequency cut-off filter at 10 Hz.

Muscle strength was evaluated via a Biodex® isokinetic dynamometer in the concentric/concentric knee extension mode at 60o/s.

Dosing of 25 OH vitamin D and thoracic spine x-rays to determine the degree of kyphosis measured by the Cobb angle were performed in the osteoporosis group.

• Study Type: Observational
• Enrollment (Actual): 126

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Postmenopausal women

Description

Inclusion Criteria:

• absence of impairment of the vestibular, proprioceptive, auditory or neurological system, and/or any mental disturbances or disorders;
• no use of medications that might compromise postural balance;
• absence of lesions, surgery or disease that might have caused lower-limb joint limitations over the previous six months;
• absence of lower-limb dysmetria;
• presence of clinically normal gait, without claudication.

Exclusion Criteria:

• the presence of pain or inability to complete any of the tests
• along with occurrences of blood pressure increase before the strength evaluation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; women with osteoporosis	Other: Biomechanical analysis; Other: Kiphosis analysis; Other: Vitamin D level
Control; women without osteoporosis	Other: Biomechanical analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
International Physical Activity Questionnaire	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional mobility	Was evaluated through the Timed Up and Go Test	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural balance	Was evaluated using a AccuSway® model portable force platform, in standard standing position, with eyes open and closed, for 60". Data were collected, stored, and processed by the Balance Clinic® program, configured to 100 Hz frequency, with a frequency cut-off filter at 10 Hz.	1 day
Muscle strength	Was evaluated via a Biodex® isokinetic dynamometer in the concentric/concentric knee extension mode at 60o/s.	1 day
Vitamin D level	Dosing of 25 OH vitamin D in a blood test	1 day
Degree of kyphosis	Thoracic spine x-rays to determine the degree of kyphosis measured by the Cobb angle were performed in the osteoporosis group	1 day

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

General Publications

• Brech GC, Ciolac EG, Peterson MD, Greve JM. Serum 25-hydroxyvitamin D levels are associated with functional capacity but not with postural balance in osteoporotic postmenopausal women. Clinics (Sao Paulo). 2017 Jan 1;72(1):11-16. doi: 10.6061/clinics/2017(01)03.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 13, 2016

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Vitamin D; Osteoporosis; Postmenopause; Muscle strength; Postural balance; Kyfhosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 320/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO