OsteoporosisNCT06947213
Orthorexia Nervosa in Postmenopausal Osteoporosis
An observational study of Osteoporosis, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
A total of 64 female patients diagnosed with osteoporosis based on dual-energy X-ray absorptiometry (DXA) measurements performed within the last six months, and 64 age-matched healthy controls without osteoporosis, will be included in our study. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Osteoporosis
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2025to 20 May 2025
- How long will I take part?
- 1 Day
- 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 55 to 75 years
- Women only
- Adult, Older adult
Study population: The study population will consist of postmenopausal women with osteoporosis and age-matched healthy controls
Who may be able to join
- Women between 55-75 years
- Women diagnosed with osteoporosis based on DXA measurements performed within the past six months.
- Women aged similarly to the osteoporosis group without a diagnosis of osteoporosis (healthy controls).
- Willingness to participate and provision of written informed consent.
Who cannot join
- Refusal to participate in the study.
- Diagnosed psychiatric disorders.
- Cognitive impairment.
- Presence of malignancy.
- Presence of endocrine disorders (e.g., hyperthyroidism, Cushing's syndrome).
- Use of glucocorticoids.
- Use of medications affecting mood.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beylikdüzü State Hospital
Istanbul, 34147
Büşra Şirin Ahısha, MD, (0212) 856 27 40, bsrn080@gmail.com
Büşra Şirin Ahısha, MD
About this study
Official title: Fragile Bones, Strong Obsessions: A Controlled Study on Orthorexia Nervosa, Body Image and Mood in Postmenopausal Women With Osteoporosis
A total of 64 female patients diagnosed with osteoporosis based on dual-energy X-ray absorptiometry (DXA) measurements performed within the last six months, and 64 age-matched healthy controls without osteoporosis, will be included in our study. Sociodemographic data such as age, sex, height, weight, and BMI will be recorded. Additionally, information regarding the duration of osteoporosis diagnosis, current treatments, history of fractures, history of falls, comorbidities, and smoking status will be collected. Femoral neck and L1-L4 T-scores and bone mineral density values obtained from existing DXA scans will be documented. Orthorexia nervosa-related symptoms will be assessed using the ORTO-11 scale, mood will be evaluated using the Hospital Anxiety and Depression Scale (HADS), and body image will be assessed using the Body Appreciation Scale-2.
- Conditions
- Osteoporosis
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
ORTO-11 Scale
The ORTO-11 assesses orthorexic tendencies, which refer to an unhealthy obsession with healthy eating. It consists of 11 items rated on a 4-point Likert scale. Total scores range from 11 to 44, with lower scores indicating a higher risk of orthorexia nervosa.
Measured: Baseline
Secondary outcomes (1)
Body Appreciation Scale-2 (BAS-2)
The BAS-2 assesses positive body image and appreciation of one's body. It consists of 10 items rated on a 5-point Likert scale (1 = Never, 5 = Always). Total scores range from 10 to 50, with higher scores indicating greater body appreciation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start20 Apr 2025
- Primary completion20 May 2025 (estimated)
- Study completion20 May 2025 (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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947213
- Sponsor's protocol ID
- Beylikdüzüstateh17
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fragile Bones, Strong Obsessions: A Controlled Study on Orthorexia Nervosa, Body Image and Mood in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT06947213
- Acronym / sponsor ID
- Beylikdüzüstateh17
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 27 Apr 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.
A total of 64 female patients diagnosed with osteoporosis based on dual-energy X-ray absorptiometry (DXA) measurements performed within the last six months, and 64 age-matched healthy controls without osteoporosis, will be included in our study. Sociodemographic data such as age, sex, height, weight, and BMI will be recorded. Additionally, information regarding the duration of osteoporosis diagnosis, current treatments, history of fractures, history of falls, comorbidities, and smoking status will be collected. Femoral neck and L1-L4 T-scores and bone mineral density values obtained from existing DXA scans will be documented. Orthorexia nervosa-related symptoms will be assessed using the ORTO-11 scale, mood will be evaluated using the Hospital Anxiety and Depression Scale (HADS), and body image will be assessed using the Body Appreciation Scale-2.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of postmenopausal women with osteoporosis and age-matched healthy controls
Key inclusion criteria (4 listed)
- Women between 55-75 years
- Women diagnosed with osteoporosis based on DXA measurements performed within the past six months.
- Women aged similarly to the osteoporosis group without a diagnosis of osteoporosis (healthy controls).
- Willingness to participate and provision of written informed consent.
Key exclusion criteria (7 listed)
- Refusal to participate in the study.
- Diagnosed psychiatric disorders.
- Cognitive impairment.
- Presence of malignancy.
- Presence of endocrine disorders (e.g., hyperthyroidism, Cushing's syndrome).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ORTO-11 Scale
Time frame: Baseline
The ORTO-11 assesses orthorexic tendencies, which refer to an unhealthy obsession with healthy eating. It consists of 11 items rated on a 4-point Likert scale. Total scores range from 11 to 44, with lower scores indicating a higher risk of orthorexia nervosa.
1 secondary outcome
Body Appreciation Scale-2 (BAS-2)
Time frame: Baseline
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 27 Apr 2025.
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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.
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 Beylikduzu State Hospital 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Apr 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 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?
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?
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?
ORTO-11 Scale (time frame: Baseline). 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 27 Apr 2025.