Status:
COMPLETED
Prevention of Glucocorticoid Induced Impairment of Bone Metabolism
Lead Sponsor:
Sahlgrenska University Hospital
Collaborating Sponsors:
BioGaia AB
Conditions:
Bone Loss
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Glucocorticoid (GC) therapy is used to treat a variety of inflammatory conditions such as rheumatoid arthritis, inflammatory bowel disease, bronchial asthma, allergies, ankylosing spondylitis and some...
Detailed Description
By advertising in newspapers, in shops, health clubs, in public places, and on social media platforms, and by contacting interested persons (by mail and phone) identified publicly available websites (...
Eligibility Criteria
Inclusion
- Healthy men and women, 18-45 years old.
- Stated availability throughout the entire study period.
- Ability to understand study instructions and willingness to adhere to the protocol.
- Signed informed consent.
- Vaccinated for Covid-19
Exclusion
- History of diabetes or glucose intolerance, defined as an abnormal oral glucose tolerance test (OGTT).
- Obesity, BMI\>30 kg/m2
- History of adrenal disease or impairment.
- Previous (within the last 5 years) or current use of antiresorptive therapy, including systemic hormone therapy (estrogen), bisphosphonates, strontium ranelate or denosumab.
- Participation in other clinical trials.
- Current antibiotics treatment or within the last 2 months prior to inclusion.
- Current and within the past 2 months use of probiotic supplement.
- Untreated hyperthyroidism or hyperthyroidism within the last 5 years.
- Known untreated hyperparathyroidism.
- Rheumatoid arthritis.
- Diagnosed with disease causing secondary osteoporosis, including chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes mellitus.
- Recently diagnosed malignancy (within the last 5 years).
- Systemic skeletal disease (including e.g. Paget's disease and osteogenesis imperfecta).
- Any systemic disease that could affect bone loss, as judged by the investigator.
- Oral corticosteroid use.
- History of peptic ulcer.
- Diagnosed osteoporosis.
- Current smoking or other use of nicotine containing products.
- Pregnancy.
- History of any psychiatric disorder, including psychosis, depression, anxiety disorder and bipolar disorder.
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04767711
Start Date
May 16 2022
End Date
December 15 2022
Last Update
February 6 2023
Active Locations (1)
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1
Geriatric Medicine, Sahlgrenska University Hospital
Mölndal, Sweden, 43180