EUCTR2015-000654-38-NO
Active, not recruiting
Phase 1
Secondary prophylaxis after hip fracture. An evaluation og two organisational models based on choise of treatment: a comparison of efficacy and applicability of hospital based treatment with zoledronate versus primary care based treatment with denosumab
Akershus University Hospital, Norway0 sites500 target enrollmentMarch 23, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hip fracture
- Sponsor
- Akershus University Hospital, Norway
- Enrollment
- 500
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Preventive efficacy for second hip fractureJPRN-UMIN000014221Japanese society for fracture repair1,500
Not yet recruiting
Not Applicable
Preventive efficacy of post-operative fracture after a total knee replacement: comparative study of PTH and anti-RANKL treatmentosteoporosisJPRN-UMIN000018048Shiga University of Medical Science100
Not yet recruiting
Not Applicable
Rehabilitation after a hip fracture: the effects of dietary protein and exercise on bone and muscle health and quality of lifebroken hipHip fracture10017322NL-OMON49870Wageningen Universiteit102
Not yet recruiting
Not Applicable
Protein for Bone and mUScle health in hip fracture patientsNL-OMON22171Division of Human Nutrition and Health of Wageningen University & Research102
Completed
Phase 2
Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care FacilitiesHip FracturesOsteoporosisNCT00280943Duke University64