NCT06238037

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2022

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

March 6, 2025

Status Verified

December 1, 2024

Enrollment Period

4.4 years

First QC Date

June 3, 2022

Last Update Submit

March 3, 2025

Conditions

SarcoidosisOsteoporosis Risk

Outcome Measures

Primary Outcomes (6)

  • Number of patients with osteoporosis

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

    At baseline

  • Number of patients with osteoporosis

    Mean BMD at 1 year and the distribution of osteopenia osteoporosis and normal scans

    1 year from diagnosis

  • Number of patients with osteoporosis

    Mean BMD at 2 years and the distribution of osteopenia osteoporosis and normal scans

    2 years from diagnosis

  • Number of patients with osteopenia

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

    At baseline

  • Number of patients with osteopenia

    Mean BMD at 1 year and the distribution of osteopenia osteoporosis and normal scans

    1 year from diagnosis

  • Number of patients with osteopenia

    Mean BMD at 2 years and the distribution of osteopenia osteoporosis and normal scans

    2 years from diagnosis

Secondary Outcomes (3)

  • Number of participants with vertebral fracture

    At baseline

  • Number of participants with vertebral fracture

    1 year from diagnosis

  • Number of participants with vertebral fracture

    2 years from diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Diagnosis of sarcoidosis
  • Signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2022

First Posted

February 2, 2024

Study Start

December 1, 2019

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

March 6, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)