OsteoporosisNCT06646549
Insomnia in Postmenopausal Osteoporosis
An observational study of Osteoporosis, run by Beylikduzu State Hospital at 2 sites in Turkey (Türkiye).
Trial summary
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 Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Osteoporosis
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 19 May 2024to 19 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with postmenopausal osteoporosis.
Who may be able to join
- Women diagnosed with postmenopausal osteoporosis.
- Patients who agreed to participate in the study.
- Age range between 50-75 years.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
Beylikdüzü State Hospital
Istanbul, 34147
About this study
Official title: The Association of Insomnia With Fatigue and Mood in Postmenopausal Osteoporosis
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
Read the detailed description
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
- Osteoporosis
- Being tested
- No intervention
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a widely used, validated tool designed to assess the nature, severity, and impact of insomnia. It is a brief, self-report questionnaire consisting of seven items that evaluate various aspects of insomnia, including difficulties falling asleep, staying asleep, waking up too early, satisfaction with sleep, interference with daily functioning, noticeable impairments, and distress caused by sleep problems.The score ranges from 0 to 28. As the score increases, the severity of insomnia worsens.
Measured: 0 day
Secondary outcomes (2)
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is a commonly used self-report tool designed to assess the impact and severity of fatigue on an individual's daily life. It consists of nine statements related to fatigue and its influence on physical and mental activities, motivation, and social functioning. Each statement is rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree), with higher scores indicating greater fatigue severity.The score ranges from 9 to 63. A higher score indicates more severe fatigue, meaning the condition worsens with increasing scores.
Measured: 0 day
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a widely used screening tool designed to identify symptoms of anxiety and depression in individuals, particularly in non-psychiatric hospital settings. It was developed to avoid reliance on physical symptoms, which may be more related to a person's medical condition rather than to anxiety or depression.Each subscale (anxiety and depression) ranges from 0 to 21. As the score increases, the severity of anxiety or depression worsens.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start19 May 2024
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
- Investigators
- Büşra Şirin Ahısha, MD, Principal investigator, Beylikdüzü State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646549
- Sponsor's protocol ID
- Beylikdüzüstateh4
- Status last verified
- Dec 2024
- First submitted
- 15 Oct 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Insomnia With Fatigue and Mood in Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT06646549
- Acronym / sponsor ID
- Beylikdüzüstateh4
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 19 May 2024 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with postmenopausal osteoporosis.
Key inclusion criteria (3 listed)
- Women diagnosed with postmenopausal osteoporosis.
- Patients who agreed to participate in the study.
- Age range between 50-75 years.
Key exclusion criteria (7 listed)
- Presence of fibromyalgia.
- Chronic fatigue syndrome.
- Chronic decompensated cardiac, renal, or hepatic failure.
- Known psychiatric disorders.
- Rheumatological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Insomnia Severity Index
Time frame: 0 day
The Insomnia Severity Index (ISI) is a widely used, validated tool designed to assess the nature, severity, and impact of insomnia. It is a brief, self-report questionnaire consisting of seven items that evaluate various aspects of insomnia, including difficulties falling asleep, staying asleep, waking up too early, satisfaction with sleep, interference with daily functioning, noticeable impairments, and distress caused by sleep problems.The score ranges from 0 to 28. As the score increases, the severity of insomnia worsens.
2 secondary outcomes
Fatigue Severity Scale
Time frame: 0 day
Hospital Anxiety and Depression Scale
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Büşra Şirin Ahısha, MD principal investigator
Beylikdüzü State Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Beylikduzu State Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: 0 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.