Status:
COMPLETED
Intraosseous Doppler Ultrasonography to Study Skeletal Physiology: Exploratory Study Before Use in Space Physiology
Lead Sponsor:
University Hospital, Angers
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-70 years
Phase:
NA
Brief Summary
Use of intraosseous Doppler ultrasonography to study skeletal physiology ("Echo-Os Study"). Exploratory study before its use in space physiology. Bones have a complex vascular network providing nutri...
Eligibility Criteria
Inclusion
- Inclusion Criteria for sub-protocol 1:
- Male aged 20-40 years
- Inclusion criteria for sub-protocol 2:
- Male aged 20-40 years \& 50-70 years
- Body height of at least 180 cm (in order to have tibia length of 43-45 cm allowing the positioning of ultrasonic probe at distal tibia, and occlusive cuff at calf level)
- Bone densitometry with available report performed within 5 last years (if none has been done, possibility to perform densitometry covered by the study at selection or inclusion visit)
- Inclusion criteria common for both sub-protocols:
- Healthy volunteer without chronic pathology (in particular no known rhythm disorder) or long-term treatment
- No symptomatic acute medical event requiring treatment on the visit days
- No history of tibia fractures
- Body Mass Index between 19 and 26
- Affiliation to the French Social Security System
- Written informed consent
- Non-Inclusion criteria:
- Inability to stay still for 20 minutes (tremor)
- Active smoking (stopped less than 1 year ago)
- History of prolonged corticosteroid treatment
- Deprivation of liberty by legal or administrative decision
- Subject to involuntary psychiatric treatment
- Subject to a legal protection measure
- For sub-study 1: Osteoporosis known at interview
- Exclusion Criteria:
- Any abnormality or deviation from the selection criteria identified during the clinical examination at the inclusion visit (non-sinus rhythm in ECG, body temperature \> 38°C, blood pressure or heart rate outside the defined standards, etc.)
Exclusion
Key Trial Info
Start Date :
March 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06206031
Start Date
March 4 2024
End Date
October 17 2024
Last Update
October 1 2025
Active Locations (2)
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1
CHU d'Angers
Angers, France, 49933
2
CHU de Saint-Etienne
Saint-Etienne, France, 42055