Current partner codePEPTIDESDE
NCT06842758·Not applicable·OBSERVATIONAL

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

Status

Active, not recruiting

Phase

Not applicable

Enrollment

40

Locations

1

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

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

Timeline

From registration to results.

  1. First posted

    Feb 24, 2025

  2. Study start

    May 1, 2023

  3. Primary completion

    May 1, 2024

  4. Study completion

    Feb 28, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Feb 24, 2025

Outcomes

What the study measures.

Primary outcomes

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

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

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
65 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

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 locations

1 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

A.O.U.P. P. Giaccone

Palermo, Italia, Italy

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

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