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NCT Number: NCT06947213

Orthorexia Nervosa in Postmenopausal 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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

Location status: Recruiting

Location contact

Büşra Şirin Ahısha, MD

CONTACT

[email protected]

(0212) 856 27 40

Büşra Şirin Ahısha, MD

PRINCIPAL_INVESTIGATOR

Fatma Nur Kesiktaş, Prof

SUB_INVESTIGATOR

Nazlı Derya Buğdaycı, Doc

SUB_INVESTIGATOR

Nurdan Paker, Prof

SUB_INVESTIGATOR

Yiğit Can Ahısha, MD

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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