Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures

February 18, 2025 updated by: Prof.ssa Giulia Letizia Mauro, University of Palermo

Multiple vertebral fragility fractures, one of the main complications of osteoporosis, are frequently associated with thoracic hyperkyphosis, which in turn leads to significant postural alterations.

These biomechanical changes may increase fall risk, posing a critical clinical issue for elderly patients. However, the results of studies investigating the association between hyperkyphosis and fall risk are conflicting, highlighting the need for further research.

This study aims to explore the correlation between the severity of thoracic kyphotic curvature and fall risk in patients with multiple fragility fractures undergoing osteoporosis treatment.

Additionally, the study seeks to evaluate the role of physiotherapy in improving patients' functional and postural outcomes.

A retrospective observational study was conducted, supplemented by a narrative literature review to contextualize the findings. Forty patients undergoing treatment at the Functional Recovery and Rehabilitation Unit (UOC) of P. Giaccone University Hospital in Palermo were enrolled and followed up via biannual phone interviews. Data were collected between May 2023 and May 2024, with a longitudinal assessment of outcomes from T0 (baseline) to T1 (12 months).

The severity of the kyphotic curve was quantified using the Cobb method, while fall risk was assessed through the Berg Balance Scale. Participation in physiotherapy programs was analyzed to evaluate their impact on clinical and functional outcomes.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italia
      • Palermo, Italia, Italy, 90127
        • A.O.U.P. P. Giaccone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A group of 40 women aged ≥65 years with the presence of at least three documented vertebral fragility fractures and a diagnosis of thoracic hyperclyphosis.

Description

Inclusion Criteria:

  • Women aged ≥65 years.
  • Presence of at least three documented vertebral fragility fractures.
  • Diagnosis of thoracic hyperkyphosis

Exclusion Criteria:

  • History of orthopedic surgeries involving the spine or lower limbs.
  • Treatments for cerebrovascular diseases.
  • Presence of balance disorders.
  • Active oncological diseases.
  • Use of walking aids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
A group of 18 women aged ≥65 years with the presence of at least three documented vertebral fragility fractures and diagnosis of thoracic hyperkyphosis.
Other: Rehabilitation Treatment
Group A patients came to our department to perform rehabilitation treatment. They underwent rehabilitation treatment for a total of 20 rehabilitation sessions, performed on a daily basis lasting 60 minutes, on a 1:1 basis with a physical therapist, . They performed postural re-education and posterior kinetic chain strengthening exercises.
Group B
A group of 22 women aged ≥65 years with the presence of at least three documented vertebral fragility fractures and diagnosis of thoracic hyperkyphosis.
Other: None Treatment
Group B patients did not undergo rehabilitation treatment. They underwent subcutaneous Teriparatide drug treatment on a daily basis for the treatment of osteoporosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Hyperkyphosis
Time Frame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);
Cobb's method by 2p radiographic examination of the whole spine
At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);
Number of falls in the last year
Time Frame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);
Evaluation of the number of falls in the last year
At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);
Balance
Time Frame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);
Assessment of balance by means of the Berg Scale
At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFR012025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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