Fracture prophylaxis after hip fracture. A comparison of effect and applicability of hospital based treatment with zoledronate versus primary care based treatement with denosumab

Phase 1

Conditions: Hip fracture
MedDRA version: 17.1Level: PTClassification code 10020100Term: Hip fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2015-000654-38-NO

Lead Sponsor: Akershus University Hospital, Norway

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. Hip fracture patients 70 years of age or older treated at Akershus University Hospital during one year (365 days) and alive 6 weeks after the fracture. This encompasses also patients 70 years of age or older with a previous hip fracture who suffer a new hip fracture during the 365 days inclusion period
A hip fracture is defined as a fracture of the neck or the region of the femur. Hip fractures complicated by subtrochanteric fracture or femural shaft fracture are not included in this definition. Other fractures in combination with the hip fracture are allowed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

1. Patients with estimated life expectancy less than 6 months
2. Patients unwilling to sign informed consent. Patients with reduced consent capabilities may participate if consent is provided by next of kin or legal guardian
3. Patients who have suffered allergic og hypersensitivity reactions to treatment with bisphosphonates or denosumab. Patients who have suffered reactions to one medication may partricipate if accepting treatment with the other.
4. Patients who are permanently bed-ridden.
5. Patients who due to other disease are not considered candidates for study participation.
6. Patients with history of osteonecrosis of the jaw or atypical femural fractures.