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Insomnia in Postmenopausal Osteoporosis

NCT ID: NCT06646549

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-19

Study Completion Date

2024-06-19

Brief Summary

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Aim of the study was to determine the presence of sleep problems in postmenopausal osteoporosis patients and to examine the relationship between the severity of insomnia and mood and fatigue. Pain, sleep problems, depression, anxiety, and fatigue were assessed using appropriate scales

Detailed Description

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The research was planned as a clinical cross-sectional study. Two hundred women, aged between 50-75 years, who were diagnosed with postmenopausal osteoporosis and followed up in the outpatient clinics of Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital between May 19, 2024, and June 19, 2024, were included. Sociodemographic data such as gender, height, weight, body mass index, educational status, and occupation were recorded. The date of osteoporosis diagnosis, history of falls within the last 6 months, presence of fractures due to low-energy trauma, osteoporosis treatment, medications used, and comorbidities were questioned. The presence and location of pain were asked, and if pain was present, its intensity was determined using the Visual Analog Scale. Calcium and vitamin D levels from the last 3 months were recorded. The patient's sleep problems were assessed using the Insomnia Severity Index. Subsequently, the patient's current depression and anxiety-related symptoms were measured using the Hospital Anxiety and Depression Scale (HADS), and the fatigue level was assessed with the Fatigue Severity Scale (FSS).

Conditions

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Osteoporosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women diagnosed with postmenopausal osteoporosis.
* Patients who agreed to participate in the study.
* Age range between 50-75 years.

Exclusion Criteria

* Presence of fibromyalgia.
* Chronic fatigue syndrome.
* Chronic decompensated cardiac, renal, or hepatic failure.
* Known psychiatric disorders.
* Rheumatological diseases.
* Presence of other known neurological diseases.
* Use of medications that enhance physical performance or alleviate fatigue.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beylikduzu State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Busra Sirin

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Büşra Şirin Ahısha, MD

Role: PRINCIPAL_INVESTIGATOR

Beylikdüzü State Hospital

Locations

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Beylikdüzü State Hospital

Istanbul, Beylikdüzü, Turkey (Türkiye)

Site Status

Beylikdüzü State Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Beylikdüzüstateh4

Identifier Type: -

Identifier Source: org_study_id