Orthorexia Nervosa in Postmenopausal Osteoporosis

April 20, 2025 updated by: Busra Sirin, Beylikduzu State Hospital

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34147
        • Recruiting
        • Beylikduzu State Hospital
        • Contact:
        • Principal Investigator:
          • Büşra Şirin Ahısha, MD
        • Sub-Investigator:
          • Nurdan Paker, Prof
        • Sub-Investigator:
          • Fatma Nur Kesiktaş, Prof
        • Sub-Investigator:
          • Nazlı Derya Buğdaycı, Doc
        • Sub-Investigator:
          • Yiğit Can Ahısha, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The study population will consist of postmenopausal women with osteoporosis and age-matched healthy controls

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Appreciation Scale-2 (BAS-2)
Time Frame: Baseline
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.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)- Anxiety Score
Time Frame: Baseline
The HADS-A subscale evaluates symptoms of anxiety. It consists of 7 items, each scored between 0 and 3. The total score ranges from 0 to 21, with higher scores indicating higher levels of anxiety.
Baseline
Hospital Anxiety and Depression Scale (HADS)- Depression Score
Time Frame: Baseline
The HADS-D subscale evaluates symptoms of depression. It consists of 7 items, each scored between 0 and 3. The total score ranges from 0 to 21, with higher scores indicating higher levels of depression.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beylikduzu State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2025

Primary Completion (Estimated)

May 20, 2025

Study Completion (Estimated)

May 20, 2025

Study Registration Dates

First Submitted

April 20, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beylikdüzüstateh17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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