Ankylosing SpondylitisNCT03866135
Bone Mineral Density, Disease Duration, and Activity in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis and Osteoporosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Our clinical study aimed to evaluate the prevalence of osteoporosis (OP) in patients with ankylosing spondylitis (AS) and to investigate the relationship between clinical, disease activity, physical function and disease duration, and bone mineral density (BMD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis, Osteoporosis, BMD
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 31 Jan 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who were admitted to the rheumatology clinic between 25 and 65 years of age and diagnosed as AS according to the modified New York diagnostic criteria were included
Who may be able to join
- Patients diagnosed as AS according to the modified New York diagnostic criteria were included
Who cannot join
- Patients previously diagnosed with OP,
- Patients previously treated with OP,
- Patients with bone fractures previously associated with OP,
- Those using drugs that affect bone metabolism, metabolic bone diseases (Paget's -disease, osteomalacia, hyperparathyroidism),
- Diabetes mellitus,
- Hypothyroidism, hyperthyroidism,
- Patients with kidney, liver and intestinal diseases,
- Those using corticosteroids
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: The Relationship Between Bone Mineral Density, Disease Duration, and Activity in Patients With Ankylosing Spondylitis
Our clinical study aimed to evaluate the prevalence of osteoporosis (OP) in patients with ankylosing spondylitis (AS) and to investigate the relationship between clinical, disease activity, physical function and disease duration, and bone mineral density (BMD).
Read the detailed description
In this cross-sectional study, patients who were admitted to the rheumatology clinic between 18 and 65 years of age and diagnosed as AS according to the modified New York diagnostic criteria were included
Patients group was divided two part as patients with (group 1)and without (group 2) osteoporosis.
The patient's global rating scale is a self-assessed scale of the patient with a grade of 10 (1: very bad, 5: moderate, 10: very good). To assess the disease activity, Bath ankylosing spondylitis disease index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were evaluated. BASDAI is a self-assessment scale used to determine disease activity in patients with AS.
Schober measurement was used to evaluate lumbar mobility of the patients. Chest expansions were measured in all patients.
Body mass index (BMI) was calculated as kg/height m2. Erythrocyte sedimentation rate (ESH mm / h), C-reactive protein (CRP mg / l) levels were measured in all patients.
BMD measurements were made by using dual-energy x-ray absorptiometry (DEXA) and lumbar vertebra (L1-4) and left femur (femoral neck and total) regions. DEXA measurements (GE / LUNAR DPX PRO) were performed and the results were recorded using standard T score. Bone mineral densities of patients were based on the World Health Organization (WHO) classification of a T score between -1 and -2.5 for osteopenia; and a score of -2.5 for osteoporosis.
- Conditions
- Ankylosing Spondylitis, Osteoporosis, BMD
- Medical subject headings
- Spondylitis, Ankylosing, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with osteoporosis | Osteoporosis has been operationally defined on the basis of bone mineral density (BMD) assessment. According to the WHO criteria, osteoporosis is defined as a BMD that lies 2.5 standard deviations or more below the average value for young healthy women (a T-score of <-2.5 SD) | |
| patients without osteoporosis | Bone mineral densities of patients were based on the World Health Organization (WHO) classification of a T score between -1 and -2.5 for osteopenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bath ankylosing spondylitis disease index (BASDAI)
BASDAI, is a widely used patient-reported outcome to measure disease activity in AS. It comprises only six questions (Box 5.1).
The answers to these questions are scored on a 0-10 NRS, which are anchored by 0 ("none") to 10 ("very severe"). The BASDAI sum score is calculated by the sum of questions 1-4 plus mean of questions 5 and 6, the total then divided by 5. The sum score ranges from 0 to 10, higher values indicate more active disease.
Measured: up to 6 month
Bath ankylosing spondylitis functional index (BASFI)
Bath Ankylosing Spondylitis Functional Index (BASFI): this is the most frequently used tool to asses function in AS. It contains 10 questions on activities of daily living, which are scored with a rating scale from 0 (no functional impairments) to 10 (maximal impairment). The sum score ranges from 0 to 10, with higher values indicating worse functioning.
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Jul 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaşar Keskin, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866135
- Sponsor's protocol ID
- 11594
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Bone Mineral Density, Disease Duration, and Activity in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT03866135
- Acronym / sponsor ID
- 11594
- Conditions
- Ankylosing Spondylitis, Osteoporosis, BMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 7 Mar 2019 (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.
Our clinical study aimed to evaluate the prevalence of osteoporosis (OP) in patients with ankylosing spondylitis (AS) and to investigate the relationship between clinical, disease activity, physical function and disease duration, and bone mineral density (BMD).
Detailed description
In this cross-sectional study, patients who were admitted to the rheumatology clinic between 18 and 65 years of age and diagnosed as AS according to the modified New York diagnostic criteria were included
Patients group was divided two part as patients with (group 1)and without (group 2) osteoporosis.
The patient's global rating scale is a self-assessed scale of the patient with a grade of 10 (1: very bad, 5: moderate, 10: very good). To assess the disease activity, Bath ankylosing spondylitis disease index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were evaluated. BASDAI is a self-assessment scale used to determine disease activity in patients with AS.
Schober measurement was used to evaluate lumbar mobility of the patients. Chest expansions were measured in all patients.
Body mass index (BMI) was calculated as kg/height m2. Erythrocyte sedimentation rate (ESH mm / h), C-reactive protein (CRP mg / l) levels were measured in all patients.
BMD measurements were made by using dual-energy x-ray absorptiometry (DEXA) and lumbar vertebra (L1-4) and left femur (femoral neck and total) regions. DEXA measurements (GE / LUNAR DPX PRO) were performed and the results were recorded using standard T score. Bone mineral densities of patients were based on the World Health Organization (WHO) classification of a T score between -1 and -2.5 for osteopenia; and a score of -2.5 for osteoporosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with osteoporosis | – | –Osteoporosis has been operationally defined on the basis of bone mineral density (BMD) assessment. According to the WHO criteria, osteoporosis is defined as a BMD that lies 2.5 standard deviations or more below the average value for young healthy women (a T-score of <-2.5 SD) |
| patients without osteoporosis | – | –Bone mineral densities of patients were based on the World Health Organization (WHO) classification of a T score between -1 and -2.5 for osteopenia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were admitted to the rheumatology clinic between 25 and 65 years of age and diagnosed as AS according to the modified New York diagnostic criteria were included
Key inclusion criteria (1 listed)
- Patients diagnosed as AS according to the modified New York diagnostic criteria were included
Key exclusion criteria (8 listed)
- Patients previously diagnosed with OP,
- Patients previously treated with OP,
- Patients with bone fractures previously associated with OP,
- Those using drugs that affect bone metabolism, metabolic bone diseases (Paget's -disease, osteomalacia, hyperparathyroidism),
- Diabetes mellitus,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bath ankylosing spondylitis disease index (BASDAI)
Time frame: up to 6 month
BASDAI, is a widely used patient-reported outcome to measure disease activity in AS. It comprises only six questions (Box 5.1). The answers to these questions are scored on a 0-10 NRS, which are anchored by 0 ("none") to 10 ("very severe"). The BASDAI sum score is calculated by the sum of questions 1-4 plus mean of questions 5 and 6, the total then divided by 5. The sum score ranges from 0 to 10, higher values indicate more active disease.
Bath ankylosing spondylitis functional index (BASFI)
Time frame: up to 6 month
Bath Ankylosing Spondylitis Functional Index (BASFI): this is the most frequently used tool to asses function in AS. It contains 10 questions on activities of daily living, which are scored with a rating scale from 0 (no functional impairments) to 10 (maximal impairment). The sum score ranges from 0 to 10, with higher values indicating worse functioning.
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 11 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Osteoporosis, run by Bezmialem Vakif University at 1 site 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 1 inclusion and 8 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 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Bath ankylosing spondylitis disease index (BASDAI) (time frame: up to 6 month). The study lists 2 primary outcomes in all. 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 11 Mar 2019.