NCT06947213

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

April 20, 2025

Last Update Submit

April 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (1)

  • Body Appreciation Scale-2 (BAS-2)

    Baseline

Other Outcomes (2)

  • Hospital Anxiety and Depression Scale (HADS)- Anxiety Score

    Baseline

  • Hospital Anxiety and Depression Scale (HADS)- Depression Score

    Baseline

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 27, 2025

Study Start

April 20, 2025

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations