NCT02771834

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Typical duration 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

July 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

May 10, 2016

Last Update Submit

May 10, 2016

Conditions

Postural Balance

Keywords

Postural balanceOsteoporosisPostmenopauseVitamin DKyfhosisMuscle strength

Outcome Measures

Primary Outcomes (1)

  • International Physical Activity Questionnaire

    1 day

Secondary Outcomes (1)

  • Functional mobility

    1 day

Other Outcomes (4)

  • Postural balance

    1 day

  • Muscle strength

    1 day

  • Vitamin D level

    1 day

  • +1 more other outcomes

Study Arms (2)

Experimental

women with osteoporosis

Other: Biomechanical analysisOther: Kiphosis analysisOther: Vitamin D level

Control

women without osteoporosis

Other: Biomechanical analysis

Interventions

Biomechanical analysisOTHER
ControlExperimental
Kiphosis analysisOTHER
Experimental
Vitamin D levelOTHER
Experimental

Eligibility Criteria

Age55 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Postmenopausal women

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28226027DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 13, 2016

Study Start

July 1, 2009

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share