OsteoporosisNCT06842758
Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures
An observational study of Osteoporosis and Hyperkyphosis, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Osteoporosis, Hyperkyphosis, Vertebral Body Fracture
- What is being tested?
- Rehabilitation Treatment and None Treatment
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Women aged ≥65 years.
- Presence of at least three documented vertebral fragility fractures.
- Diagnosis of thoracic hyperkyphosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Rehabilitation Treatment, None Treatment
- Keywords
- osteoporosis, Hyperkyphosis, vertebral body fracture, rehabilitation
- Medical subject headings
- Osteoporosis, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation TreatmentOther
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 TreatmentOther
Group B patients did not undergo rehabilitation treatment. They underwent subcutaneous Teriparatide drug treatment on a daily basis for the treatment of osteoporosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: None Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Hyperkyphosis
Cobb's method by 2p radiographic examination of the whole spine
Measured: 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
Measured: 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
Measured: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842758
- Sponsor's protocol ID
- MFR012025
- Status last verified
- Jan 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33802536Tarantino 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.
PubMed 29058226Cultrera 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.
PubMed 22460016
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures
- ClinicalTrials.gov ID
- NCT06842758
- Acronym / sponsor ID
- MFR012025
- Conditions
- Osteoporosis, Hyperkyphosis, Vertebral Body Fracture
- Keywords
- osteoporosis, Hyperkyphosis, vertebral body fracture, rehabilitation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Rehabilitation TreatmentA group of 18 women aged ≥65 years with the presence of at least three documented vertebral fragility fractures and diagnosis of thoracic hyperkyphosis. |
| Group B | – | Other: None TreatmentA group of 22 women aged ≥65 years with the presence of at least three documented vertebral fragility fractures and diagnosis of thoracic hyperkyphosis. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Women aged ≥65 years.
- Presence of at least three documented vertebral fragility fractures.
- Diagnosis of thoracic hyperkyphosis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation TreatmentGroup 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 | Group A |
| None TreatmentGroup B patients did not undergo rehabilitation treatment. They underwent subcutaneous Teriparatide drug treatment on a daily basis for the treatment of osteoporosis | Other | Group B |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 33802536Scaturro 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.
- Background: PubMed 29058226Tarantino 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.
- Background: PubMed 22460016Cultrera 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Hyperkyphosis, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Hyperkyphosis (time frame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06842758, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.