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

NCT06842758 | Active Not Recruiting DMC

• 1 other identifier: MFR012025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis; Hyperkyphosis; Vertebral Body Fracture

Keywords

osteoporosis; Hyperkyphosis; vertebral body fracture; rehabilitation

Outcome Measures

Primary Outcomes (3)

• Degree of Hyperkyphosis

  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

  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

  Assessment of balance by means of the Berg Scale

  At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);

Study Arms (2)

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 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

Interventions

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.

Group A

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

Group B

Eligibility Criteria

• Age: 65 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

A.O.U.P. P. Giaccone

Palermo, Italia, 90127, Italy

Location

Related Publications (3)

• Scaturro D, Rizzo S, Sanfilippo V, Giustino V, Messina G, Martines F, Falco V, Cuntrera D, Moretti A, Iolascon G, Letizia Mauro G. Effectiveness of Rehabilitative Intervention on Pain, Postural Balance, and Quality of Life in Women with Multiple Vertebral Fragility Fractures: A Prospective Cohort Study. J Funct Morphol Kinesiol. 2021 Mar 3;6(1):24. doi: 10.3390/jfmk6010024.

  PMID: 33802536 BACKGROUND

• Tarantino U, Iolascon G, Cianferotti L, Masi L, Marcucci G, Giusti F, Marini F, Parri S, Feola M, Rao C, Piccirilli E, Zanetti EB, Cittadini N, Alvaro R, Moretti A, Calafiore D, Toro G, Gimigliano F, Resmini G, Brandi ML. Clinical guidelines for the prevention and treatment of osteoporosis: summary statements and recommendations from the Italian Society for Orthopaedics and Traumatology. J Orthop Traumatol. 2017 Nov;18(Suppl 1):3-36. doi: 10.1007/s10195-017-0474-7.

  PMID: 29058226 BACKGROUND

• Cultrera P, Pratelli E, Petrai V, Postiglione M, Zambelan G, Pasquetti P. Evaluation with stabilometric platform of balance disorders in osteoporosis patients. A proposal for a diagnostic protocol. Clin Cases Miner Bone Metab. 2010 May;7(2):123-5.

  PMID: 22460016 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Kyphosis

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Curvatures; Spinal Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: February 28, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)