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Clinical Trials/NCT06947213
NCT06947213
Recruiting
Not Applicable

Fragile Bones, Strong Obsessions: A Controlled Study on Orthorexia Nervosa, Body Image and Mood in Postmenopausal Women With Osteoporosis

Beylikduzu State Hospital1 site in 1 country128 target enrollmentStarted: April 20, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Beylikduzu State Hospital
Enrollment
128
Locations
1
Primary Endpoint
ORTO-11 Scale

Overview

Brief 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. 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

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
55 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Body Appreciation Scale-2 (BAS-2)(Baseline)

Investigators

Sponsor
Beylikduzu State Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Busra Sirin

Principle Investigator

Beylikduzu State Hospital

Study Sites (1)

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