Bone Mineral Density in Patients With Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Bone Mineral Density in Patients With Sarcoidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238037
• Other study ID #: SAR4
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2023
• Source: University of Aarhus
• Contact: Janne Møller, MD
• Phone: 0045 78462201
• Email: jannmoel[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the frequency and risk factors of decreased bone mineral density (BMD) and vertebral fractures in Danish patients with sarcoidosis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of sarcoidosis
• Signed informed consent

Exclusion Criteria:

• Inability or unwillingness to adhere to the study
• Inability to give informed consent

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Risk
• Sarcoidosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with osteoporosis	Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans	At baseline
Primary	Number of patients with osteoporosis	Mean BMD at 1 year and the distribution of osteopenia osteoporosis and normal scans	1 year from diagnosis
Primary	Number of patients with osteoporosis	Mean BMD at 2 years and the distribution of osteopenia osteoporosis and normal scans	2 years from diagnosis
Primary	Number of patients with osteopenia	Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans	At baseline
Primary	Number of patients with osteopenia	Mean BMD at 1 year and the distribution of osteopenia osteoporosis and normal scans	1 year from diagnosis
Primary	Number of patients with osteopenia	Mean BMD at 2 years and the distribution of osteopenia osteoporosis and normal scans	2 years from diagnosis
Secondary	Number of participants with vertebral fracture	Proportion of patients with vertebral fracture	At baseline
Secondary	Number of participants with vertebral fracture	Proportion of patients with vertebral fracture	1 year from diagnosis
Secondary	Number of participants with vertebral fracture	Proportion of patients with vertebral fracture	2 years from diagnosis