Bone Mineral Density in Patients With Sarcoidosis

January 24, 2024 updated by: University of Aarhus
To assess the frequency and risk factors of decreased bone mineral density (BMD) and vertebral fractures in Danish patients with sarcoidosis.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Janne Møller, MD
  • Phone Number: 0045 78462201
  • Email: jannmoel@rm.dk

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with sarcoidosis seen in dep. of Respiratory Diseases and Allergology, Aarhus University Hospital

Description

Inclusion Criteria:

  • Diagnosis of sarcoidosis
  • Signed informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with osteoporosis
Time Frame: At baseline
Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans
At baseline
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
1 year from diagnosis
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
2 years from diagnosis
Number of patients with osteopenia
Time Frame: At baseline
Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans
At baseline
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
1 year from diagnosis
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
2 years from diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with vertebral fracture
Time Frame: At baseline
Proportion of patients with vertebral fracture
At baseline
Number of participants with vertebral fracture
Time Frame: 1 year from diagnosis
Proportion of patients with vertebral fracture
1 year from diagnosis
Number of participants with vertebral fracture
Time Frame: 2 years from diagnosis
Proportion of patients with vertebral fracture
2 years from diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

June 3, 2022

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Estimated)

February 2, 2024

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAR4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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