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 ICU
Conditions
Interventions
Trade Name: Prolia
Product Name: Denosumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Denosumab
CAS Number: 615258-40-7
Other descriptive name: Immunoglobulin G2 Human Monoclonal
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: twofold: a) to evaluate if a single administration of denosumab decreases bone resorption (CTX-1) within one month in immobilized patients b) to evaluate if one year of denosumab therapy has a positive effect on the immobilization-associated bone loss. (hip region) Additionally, potential changes of BTMs will be evaluated. Pilot study (n=14): evaluate if a single administration of denosumab decreases bone resorption (CTX-1) within one month in immobilized patients;Secondary Objective: a) Serum levels of osteocalcin (Oc), bone-spcific alkaline Phosphatase (BAP), procollagen ta) pe 1 amino-terminal propeptide (P1NP), Tartate resistante acid phosphatase (TRAP), dickkopf 1 (DKK1), sclerostin (SOST), periostin (PSTN), 24-h urine: Ca excretion one month and twelve months after 1st denosumab application b) BMD: T-score lumbar spine twelve months after 1st denosumab application c) Reasons for drop outs Pilot study (n=14): cortical thickness and density index of the proximal tibia (quantitative ultrasound) - characterization of subjects;Primary end point(s): a) Serum levels of carboxy-terminal collagen crosslinks (CTX-1) one month after first denosumab application b) BMD of the hip region one year after the first denosumab application Pilot study (n=14): Serum levels of carboxy-terminal collagen crosslinks (CTX-1) one month after denosumab application;Timepoint(s) of evaluation of this end point: a) CTX-1: before first denosumab application, one month after first denosumab application b) BMD: one month and 12 months after first denosumab application Pilot study (n=14): cortical thickness and density index of the proximal tibia (quantitative ultrasound): within one week after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Biochemical parameters: before first denosumab application, one month, 6 and 12 months after first denosumab application BMD: one month and 12 months after first denosumab application Reasons for drop outs: on occasion ;Secondary end point(s): a) Serum levels of osteocalcin (Oc), bone-spcific alkaline Phosphatase (BAP), procollagen type 1 amino-terminal propeptide (P1NP), Tartate resistante acid phosphatase (TRAP), dickkopf 1 (DKK1), sclerostin (SOST), periostin (PSTN), 24-h urine: Ca excretion one month and twelve months after 1st denosumab application b) BMD: T-score lumbar spine twelve months after 1st denosumab application c) Reasons for drop outs | — |
Countries
Austria
Contacts
Public ContactClincial Trial Information Desk
Medical University of Vienna
Outcome results
None listed