E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020100 |
E.1.2 | Term | Hip fracture |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
1. Testing and developing an organizational model for primary care post fracture prophylaxis 2.Quality of life assessment during follow up after hip fracture |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | 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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E.5.2 | 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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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |