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NCT Number: NCT06842758

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

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.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

A.O.U.P. P. Giaccone

Palermo, Italia, 90127, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Rehabilitation treatment

Other

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.

None Treatment

Other

Group B patients did not undergo rehabilitation treatment. They underwent subcutaneous Teriparatide drug treatment on a daily basis for the treatment of osteoporosis

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

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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