SarcoidosisNCT06238037
Bone Mineral Density in Patients With Sarcoidosis
An observational study of Sarcoidosis and Osteoporosis Risk, run by University of Aarhus at 1 site in Denmark.
Trial summary
To assess the frequency and risk factors of decreased bone mineral density (BMD) and vertebral fractures in Danish patients with sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Osteoporosis Risk
- How many people
- 144 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2019to 30 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sarcoidosis seen in dep. of Respiratory Diseases and Allergology, Aarhus University Hospital
Who may be able to join
- Diagnosis of sarcoidosis
- Signed informed consent
Who cannot join
- Inability or unwillingness to adhere to the study
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology
Aarhus N, 8200
About this study
To assess the frequency and risk factors of decreased bone mineral density (BMD) and vertebral fractures in Danish patients with sarcoidosis.
Read the detailed description
An increased risk of bone fracture has been found in patients with sarcoidosis. Some data showed that the risk of fracture was limited to patients treated with glucocorticoid but data are conflicting and not all studies can prove an increased risk of fracture or bone mineral loss in sarcoidosis.
- Conditions
- Sarcoidosis, Osteoporosis Risk
- Medical subject headings
- Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with osteoporosis
Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans
Measured: At baseline
Number of patients with osteoporosis
Mean BMD at 1 year and the distribution of osteopenia osteoporosis and normal scans
Measured: 1 year from diagnosis
Number of patients with osteoporosis
Mean BMD at 2 years and the distribution of osteopenia osteoporosis and normal scans
Measured: 2 years from diagnosis
Number of patients with osteopenia
Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans
Measured: At baseline
Number of patients with osteopenia
Mean BMD at 1 year and the distribution of osteopenia osteoporosis and normal scans
Measured: 1 year from diagnosis
Number of patients with osteopenia
Mean BMD at 2 years and the distribution of osteopenia osteoporosis and normal scans
Measured: 2 years from diagnosis
Secondary outcomes (3)
Number of participants with vertebral fracture
Proportion of patients with vertebral fracture
Measured: At baseline
Number of participants with vertebral fracture
Proportion of patients with vertebral fracture
Measured: 1 year from diagnosis
Number of participants with vertebral fracture
Proportion of patients with vertebral fracture
Measured: 2 years from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Dec 2019
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238037
- Sponsor's protocol ID
- SAR4
- Status last verified
- Dec 2024
- First submitted
- 3 Jun 2022
- Last updated
- 6 Mar 2025
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density in Patients With Sarcoidosis
- ClinicalTrials.gov ID
- NCT06238037
- Acronym / sponsor ID
- SAR4
- Conditions
- Sarcoidosis, Osteoporosis Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 2 Feb 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.
To assess the frequency and risk factors of decreased bone mineral density (BMD) and vertebral fractures in Danish patients with sarcoidosis.
Detailed description
An increased risk of bone fracture has been found in patients with sarcoidosis. Some data showed that the risk of fracture was limited to patients treated with glucocorticoid but data are conflicting and not all studies can prove an increased risk of fracture or bone mineral loss in sarcoidosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sarcoidosis seen in dep. of Respiratory Diseases and Allergology, Aarhus University Hospital
Key inclusion criteria (2 listed)
- Diagnosis of sarcoidosis
- Signed informed consent
Key exclusion criteria (2 listed)
- Inability or unwillingness to adhere to the study
- Inability to give informed consent
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
Number of patients with osteoporosis
Time frame: At baseline
Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans
Number of patients with osteoporosis
Time frame: 1 year from diagnosis
Mean BMD at 1 year and the distribution of osteopenia osteoporosis and normal scans
Number of patients with osteoporosis
Time frame: 2 years from diagnosis
Mean BMD at 2 years and the distribution of osteopenia osteoporosis and normal scans
Number of patients with osteopenia
Time frame: At baseline
Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans
Number of patients with osteopenia
Time frame: 1 year from diagnosis
Mean BMD at 1 year and the distribution of osteopenia osteoporosis and normal scans
Number of patients with osteopenia
Time frame: 2 years from diagnosis
Mean BMD at 2 years and the distribution of osteopenia osteoporosis and normal scans
3 secondary outcomes
Number of participants with vertebral fracture
Time frame: At baseline
Number of participants with vertebral fracture
Time frame: 1 year from diagnosis
Number of participants with vertebral fracture
Time frame: 2 years from diagnosis
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 6 Mar 2025.
- Individual participant dataSharing planned: No
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Cardiac Sarcoidosis Multi-Center Prospective Cohort
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A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
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Not yet recruitingPhase 2
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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 Sarcoidosis and Osteoporosis Risk, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 2 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 6 Mar 2025. 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 Denmark. 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?
Number of patients with osteoporosis (time frame: At baseline). The study lists 6 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 6 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.