Denosumab in the prevention of immobilization-induced bone loss in Intensive Care Unit patients
- Conditions
- Immobilization because of aneurysmal subarachnoidal haemorrhage (aSAH) with moderate-severe neurological deficits (e.g. hemiparesis) and reduced state of consciousness – equivalent to Hunt&Hess 4-5 – at the time of admission to ICUTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2018-000552-18-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
Women, men
30-80 years of age
Patients after aneurysmal subarachnoidal haemorrhage (aSAH) with moderate-severe neurological deficits (e.g. hemiparesis) and reduced state of consciousness – equivalent to Hunt&Hess 4-5 – at the time of admission to ICU
Normal liver function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
Patients after aneurysmal subarachnoidal haemorrhage (aSAH; Hunt&Hess 0-3)
Patients after intracerebral bleeding
Subjects with a history of prior solid organ transplantation
Cancer within the previous 5 years
Pregnancy
Rheumatoid arthritis
Severe renal insufficiency (CKD V)
Intake of drugs with potential effects on BMD like lithium, estrogen-replacement therapy, selective estrogen-receptor modulators (SERMS), oral bisphosphonates in the last three months, denosumab and parenteral bisphosphonates in the last year - except medication necessary for the underlying disease
Non-osteoporotic bone disease
Recent fragility fracture within 6 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method