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Completed

NCT Number: NCT06238037

Bone Mineral Density in Patients With Sarcoidosis

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

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Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Osteoporosis Risk

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of sarcoidosis
  • Signed informed consent

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of patients with osteoporosis

    Time frame: At baseline

    Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans

  2. 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

  3. 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

  4. Number of patients with osteopenia

    Time frame: At baseline

    Mean BMD at baseline and the distribution of osteopenia osteoporosis and normal scans

  5. 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

  6. 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

Secondary outcomes

  1. Number of participants with vertebral fracture

    Time frame: At baseline

    Proportion of patients with vertebral fracture

  2. Number of participants with vertebral fracture

    Time frame: 1 year from diagnosis

    Proportion of patients with vertebral fracture

  3. Number of participants with vertebral fracture

    Time frame: 2 years from diagnosis

    Proportion of patients with vertebral fracture

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2024
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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