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OpenTrials
Completed

NCT Number: NCT02771834

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.

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Key information

Age range

55 year–65 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biomechanical analysis

Other

Kiphosis analysis

Other

Vitamin D level

Other

Primary outcomes

  1. International Physical Activity Questionnaire

    Time frame: 1 day

Secondary outcomes

  1. Functional mobility

    Time frame: 1 day

    Was evaluated through the Timed Up and Go Test

Other outcomes

  1. Postural balance

    Time frame: 1 day

    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.

  2. Muscle strength

    Time frame: 1 day

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

  3. Vitamin D level

    Time frame: 1 day

    Dosing of 25 OH vitamin D in a blood test

  4. Degree of kyphosis

    Time frame: 1 day

    Thoracic spine x-rays to determine the degree of kyphosis measured by the Cobb angle were performed in the osteoporosis group

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 13, 2016
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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