OsteoporosisNCT06475794
Investigation of Q Angle in Osteoporosis Patients
An observational study of Osteoporosis, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Patients with osteoporosis group and Patients with osteoarthritis group
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2024to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are willing to participate in the study, being between the ages of 40-65 will be included in the study. Patients who have patellofemoral abnormalities during examination, acute traumatic patellofemoral dislocations, surgical revision around the knee, history of any previous lower extremity surgery and serious trauma will be excluded from the study.
Who may be able to join
- Be willing to participate in the study.
- Being between the ages of 40-65.
- Being a woman.
Who cannot join
- Patellofemoral abnormalities during examination.
- Acute traumatic patellofemoral dislocations
- Surgical revision around the knee
- History of any previous lower extremity surgery
- Serious trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Elâzığ, 23100
Songul Baglan Yentur, 04242370000, songulbaglan23@hotmail.com
Songul Baglan Yentur, songulbaglan23@hotmail.com
About this study
Official title: Investigation of Q Angle and Related Factors in Osteoporosis Patients
Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).
Read the detailed description
Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. According to Calis et al; it was found that patients with hip fracture had a significantly higher Q angle compared to patients without hip fracture. According to You et al; contraction of the quadriceps muscles corrects the Q angle, therefore sports that use high amounts of quadriceps (strength) training are associated with lower Q angles due to the pulling effect of the quadriceps muscle. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).
- Conditions
- Osteoporosis
- Being tested
- Patients with osteoporosis group, Patients with osteoarthritis group
- Keywords
- Osteoporosis, Osteopenia, Q angle
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with osteoporosis groupOther
Pain, Q angle, muscle strength and foot posture will be evaluated.
Patients with osteoarthritis groupOther
Osteoarthritis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength.
| Study group | Role | What they receive |
|---|---|---|
| Patients with osteoporosis group | Osteoporosis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength. Receives: Other: Patients with osteoporosis group | |
| Patients with osteoarthritis group | Osteoarthritis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength. Receives: Other: Patients with osteoarthritis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Q angle assessment
Q angle will be evaluated with goniometer.
Measured: 1 minute
Secondary outcomes (3)
Pain assessment
Pain assessment will be done with the Visual Analog Scale (VAS). This measurement is performed with a chart in which no pain is written on one end and very severe pain is written on the other end.
Measured: 1 minute
Muscle strength assessment
Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Muscle strength is graded on a scale of 0 to 5 according to muscle tone and ability to resist the force of gravity.
Measured: 2 minutes
Foot posture assessment
Foot posture will be evaluated with the Foot Posture Index (FPI). API is an easy-to-apply, valid and reliable method that provides information about the degree of pronation and supination of the foot with a single numerical result and evaluates the foot in a multidimensional and comprehensive manner.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475794
- Sponsor's protocol ID
- 2024/07-33
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Q Angle and Related Factors in Osteoporosis Patients
- ClinicalTrials.gov ID
- NCT06475794
- Acronym / sponsor ID
- 2024/07-33
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Osteopenia, Q angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 26 Jun 2024 (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.
Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).
Detailed description
Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. According to Calis et al; it was found that patients with hip fracture had a significantly higher Q angle compared to patients without hip fracture. According to You et al; contraction of the quadriceps muscles corrects the Q angle, therefore sports that use high amounts of quadriceps (strength) training are associated with lower Q angles due to the pulling effect of the quadriceps muscle. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with osteoporosis group | – | Other: Patients with osteoporosis groupOsteoporosis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength. |
| Patients with osteoarthritis group | – | Other: Patients with osteoarthritis groupOsteoarthritis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are willing to participate in the study, being between the ages of 40-65 will be included in the study. Patients who have patellofemoral abnormalities during examination, acute traumatic patellofemoral dislocations, surgical revision around the knee, history of any previous lower extremity surgery and serious trauma will be excluded from the study.
Key inclusion criteria (3 listed)
- Be willing to participate in the study.
- Being between the ages of 40-65.
- Being a woman.
Key exclusion criteria (5 listed)
- Patellofemoral abnormalities during examination.
- Acute traumatic patellofemoral dislocations
- Surgical revision around the knee
- History of any previous lower extremity surgery
- Serious trauma
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 |
|---|---|---|
| Patients with osteoporosis groupPain, Q angle, muscle strength and foot posture will be evaluated. | Other | Patients with osteoporosis group |
| Patients with osteoarthritis groupOsteoarthritis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength. | Other | Patients with osteoarthritis group |
Primary outcome
Q angle assessment
Time frame: 1 minute
Q angle will be evaluated with goniometer.
3 secondary outcomes
Pain assessment
Time frame: 1 minute
Muscle strength assessment
Time frame: 2 minutes
Foot posture assessment
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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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.
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, run by Firat University at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Q angle assessment (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2024.