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The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture The main questions it aims to answer are: It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration. The primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the New Mobility Score. Participants will: \- Receive either a single dose of intravenous FDI (20 mg/kg body weight) (and saline) or placebo (saline) at 1-5 days after surgery. This trial will be conducted at three hospitals in Denmark, involving an anticipated 210 participants.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 65 years of age or older

• Acute proximal femur fracture surgery

• A hemoglobin measurement ≤6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively

• Independent prefracture indoor walking ability, indoor NMS ≥ 2

• Ability to speak and understand Danish

• Able to provide informed consent on the participants own behalf

Locations
Other Locations
Denmark
Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital
ACTIVE_NOT_RECRUITING
Copenhagen Nv
Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital
RECRUITING
Herlev
Department of Orthopaedic Surgery, Odense and Svendborg University Hospital
RECRUITING
Odense C
Contact Information
Primary
Nicolas Tekin Jones, MD
nicolas.tekin.jones@regionh.dk
+4520491890
Backup
Søren Overgaard, MD, DMSc
soeren.overgaard@regionh.dk
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2027-09-14
Participants
Target number of participants: 210
Treatments
Active_comparator: Active Investigational Medicinal Product
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Soren Overgaard
Collaborators: University Hospital Bispebjerg and Frederiksberg, Musculoskeletal Statistics Unit, The Parker Institute, Odense University Hospital, Svendborg Hospital, Copenhagen University Hospital at Herlev

This content was sourced from clinicaltrials.gov

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