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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000654-38-NO

Enrollment

500

Registered

2015-03-23

Start date

2015-10-19

Completion date

Unknown

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fracture MedDRA version: 17.1 Level: PT Classification code 10020100 Term: Hip fracture System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Aclasta (or generic equivalent) Pharmaceutical Form: Infusion Trade Name: Prolia Pharmaceutical Form: Solution and suspension for suspension for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study applicability, feasibility, patient and health workers preference of secondary fracture prophylaxis after hip fracture using two different organizational models based on choice of treatment: a hospital based treatment with zoleronate versus primary care based treatment with denosumab;Secondary Objective: 1. Testing and developing an organizational model for primary care post fracture prophylaxis 2.Quality of life assessment during follow up after hip fracture;Primary end point(s): 1. Assessment of applicability and feasability of medical fracture prophylaxis after hip fracture in patients alive after 6 weeks in a real-life setting. 2. Bone mineral density by DXA at inclusion and after 1 and 2 years of medical fracture prophylaxis after hip fracture – comparison between treatment groups. 3. Incident fractures – comparison between treatment groups and between treatment groups and historical controls. 4. Evaluation of feasibility and efficacy of two different organizational models for medical fracture prophylaxis after hip fracture using either hospital based zoledronate treatment or primary care based treatment with denosumab. ;Timepoint(s) of evaluation of this end point: When last patient included and still alive has received treatment for 2 years	—

Measure

Time frame

Main Objective: To study applicability, feasibility, patient and health workers preference of secondary fracture prophylaxis after hip fracture using two different organizational models based on choice of treatment: a hospital based treatment with zoleronate versus primary care based treatment with denosumab;Secondary Objective: 1. Testing and developing an organizational model for primary care post fracture prophylaxis 2.Quality of life assessment during follow up after hip fracture;Primary end point(s): 1. Assessment of applicability and feasability of medical fracture prophylaxis after hip fracture in patients alive after 6 weeks in a real-life setting. 2. Bone mineral density by DXA at inclusion and after 1 and 2 years of medical fracture prophylaxis after hip fracture – comparison between treatment groups. 3. Incident fractures – comparison between treatment groups and between treatment groups and historical controls. 4. Evaluation of feasibility and efficacy of two different organizational models for medical fracture prophylaxis after hip fracture using either hospital based zoledronate treatment or primary care based treatment with denosumab. ;Timepoint(s) of evaluation of this end point: When last patient included and still alive has received treatment for 2 years

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: When last patient included and still alive has received treatment for 2 years;Secondary end point(s): 1. Prevalence of previous or ongoing osteoporosis treatment among hip fracture patients 2. Vitamin D levels at inclusion and after 1 and 2 years of treatment 3. X-ray of the spine at inclusion for prevalent fractures (semi quantitative method) 4. Comparison of incidence of prevalent vertebral fractures using X-ray versus lateral DXA (LVA) at inclusion. 5. Lateral DXA (LVA) for incident vertebral fractures at 1 and 2 years of treatment. 6. Sub-group analysis of changes in BMD during treatment (age, sex, weight, previous fractures, incident fractures, BMD at inclusion, previous osteoporosis treatment, renal function, ASA-score). 7. Comparison of mortality between treatment groups and between treatment groups and historical controls. 8. Comparion of SAE between treatment groups. 9. Comparison of delayed fracture union, ONJ and atypical fractures between treatment groups. 10. Quality of life using ECOS-16 at inclusion and after 1 and 2 years. 11. Mini Mental State at inclusion and after 1 and 2 years. 12. EQ-5D at inclusion and after 1 and 2 years. 13. Evaluation of patients opinion of importance and feasibility of medical fracture prophylaxis using a questionnaire. 14. Evaluation of health workers including doctors opinion of importance and feasibility of medical fracture prophylaxis using a questionnaire.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: When last patient included and still alive has received treatment for 2 years;Secondary end point(s): 1. Prevalence of previous or ongoing osteoporosis treatment among hip fracture patients 2. Vitamin D levels at inclusion and after 1 and 2 years of treatment 3. X-ray of the spine at inclusion for prevalent fractures (semi quantitative method) 4. Comparison of incidence of prevalent vertebral fractures using X-ray versus lateral DXA (LVA) at inclusion. 5. Lateral DXA (LVA) for incident vertebral fractures at 1 and 2 years of treatment. 6. Sub-group analysis of changes in BMD during treatment (age, sex, weight, previous fractures, incident fractures, BMD at inclusion, previous osteoporosis treatment, renal function, ASA-score). 7. Comparison of mortality between treatment groups and between treatment groups and historical controls. 8. Comparion of SAE between treatment groups. 9. Comparison of delayed fracture union, ONJ and atypical fractures between treatment groups. 10. Quality of life using ECOS-16 at inclusion and after 1 and 2 years. 11. Mini Mental State at inclusion and after 1 and 2 years. 12. EQ-5D at inclusion and after 1 and 2 years. 13. Evaluation of patients opinion of importance and feasibility of medical fracture prophylaxis using a questionnaire. 14. Evaluation of health workers including doctors opinion of importance and feasibility of medical fracture prophylaxis using a questionnaire.

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Countries

Norway

Contacts

Public ContactDr. Christian Pollmann

Akershus University Hospital, Norway

Christian.Pollmann@AHUS.no+4702900

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026