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

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ClinicalTrials.gov Identifier: NCT02771834
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Guilherme Carlos Brech, University of Sao Paulo

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

Condition or disease Intervention/treatment
Postural Balance 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
Actual Enrollment : 126 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women
Study Start Date : July 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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



Primary Outcome Measures :
  1. International Physical Activity Questionnaire [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Functional mobility [ Time Frame: 1 day ]
    Was evaluated through the Timed Up and Go Test


Other Outcome Measures:
  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



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Ages Eligible for Study:   55 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Postmenopausal women
Criteria

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guilherme Carlos Brech, Phd, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02771834     History of Changes
Other Study ID Numbers: 320/09
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Guilherme Carlos Brech, University of Sao Paulo:
Postural balance
Osteoporosis
Postmenopause
Vitamin D
Kyfhosis
Muscle strength

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents