CClinicalTrials.gg
CompletedNCT02771834Updated May 13, 2016

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

An observational study in Postural Balance, sponsored by University of Sao Paulo. Completed. Open to female participants aged 55 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-13.

Sponsored by University of Sao Paulo · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
126
Ages
55 Years to 65 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Postural Balance

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Keywords

  • Postural balance
  • Osteoporosis
  • Postmenopause
  • Vitamin D
  • Kyfhosis
  • Muscle strength
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 126 is below the median of 174 across 446 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Postmenopausal women

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
126 participants (actual)
Patient registry
No

Groups and cohorts

  • Experimental

    women with osteoporosis

    Other: Biomechanical analysis · Other: Kiphosis analysis · Other: Vitamin D level

  • Control

    women without osteoporosis

    Other: Biomechanical analysis

Interventions

  • OtherBiomechanical analysis
  • OtherKiphosis analysis
  • OtherVitamin D level
06

What researchers measure

Primary outcomes

  1. International Physical Activity Questionnaire

    Time frame: 1 day

Secondary outcomes

  1. Functional mobility

    Was evaluated through the Timed Up and Go Test

    Time frame: 1 day

Other outcomes

  1. 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.

    Time frame: 1 day

  2. Muscle strength

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

    Time frame: 1 day

  3. Vitamin D level

    Dosing of 25 OH vitamin D in a blood test

    Time frame: 1 day

  4. Degree of kyphosis

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

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 28226027 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02771834
Lead sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Guilherme Carlos Brech (Phd, University of Sao Paulo) — Principal investigator
First posted
May 13, 2016
Start date
Jul 2009
Primary completion
Jul 2012
Completion
Dec 2012
Last update
May 13, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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