Clinical trial NCT06842758: Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures
Official title: Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoporosis
Hyperkyphosis
Vertebral Body Fracture
Keywords: osteoporosis
Hyperkyphosis
vertebral body fracture
rehabilitation
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Degree of Hyperkyphosis
timeFrame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);
measure: Number of falls in the last year
timeFrame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);
measure: Balance
timeFrame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: A.O.U.P. P. Giaccone
state: Italia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.