E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with idiopathic osteoarthritis of the knee, scheduled for a cemented total knee prosthesis |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of denosumab compared with placebo regarding the maximal total point motion by radiostereometric assay (MTPM by RSA) at one year. |
Att utvärdera effekten av denosumab jämfört med placebo beträffande maximalrörelseförmåga mätt med röntgen stereometri efter ett år. |
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E.2.2 | Secondary objectives of the trial |
To compare denosumab with placebo regarding translation and rotation in relation to the x, y and z axes the day after operation and after 6 months, 1 year, 2 years and 4 years.
To compare denosumab with placebo regarding patient reported function using the KOOS questionnaire after 1, 2 and 4 years.
To compare the treatments regarding MTPM by RSA after 2 and 4 years.
To compare safety and tolerance of denosumab compared with placebo during the study period.
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Att jämföra denosumab med placebo avseende translation och rotation i relation till x, y och z axlarna dagen efter operation och efter 6 månader, 1 år, 2 år och 4 år.
Att jämföra denosumab med placebo avseende patientrapporterad funktion med KOOS frågeformulär efter 1, 2 och 4 år.
Att jämföra behandlingarna avseende MTPM med RSA efter 2 och 4 år.
Att jämföra säkerhet och tolerabilitet av denosumab jämfört med placebo under studieperioden. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Man or postmenopausal woman
• 55-80 years of age
• Idiopathic osteoarthritis of the knee
• Scheduled for a cemented total knee prosthesis
• Signed informed consent given
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- Man eller postmenopausal kvinna
- 55-80 år
- Idiopatisk knäosteoartrit
- Schemalagd för cementerad total knäprotes
- Undertecknat informerat samtycke |
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E.4 | Principal exclusion criteria |
• Previous or present use of bisphosphonates
• Present use of other drugs which influence bone, e.g. anti-osteoporotic agents, glucocorticoids, anti-epileptics, or use less than a year before randomization
• Cardiac disease limiting physical activities; ASA class 3 or 4
• Active malignant disease
• Previous radiation therapy
• Metabolic disease (other than osteoporosis) affecting the skeleton.
• Rheumatic disease
• Hypocalcemia
• Hypersensitivity to Prolia or to any of the excipients
• Simultaneous bilateral surgery
• Communication problems (drug abuse, language or behavior problems).
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- Metabolisk sjukdom ( annan än osteoartrit
- Reumatisk sjukdom
- Hypokalcemi
- Överkänslighet mot Prolia eller till någon av dess beståndsdelar
- Samtidig bilateral kirurgi
- Kommunikationsproblem (läkemdelsmissbruk, språk eller uppförandeproblem) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficay variable is the maximal total poimt motion by radiostereometric assay (MTPM by RSA) at one year. |
Den primära eefekrvariabeln är maximalrörelseförmåga mätt med RSA efter ett år. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Knee injury and Osteoarthritis Outcome Score (KOOS) at 12 months and a combination of the RSA variables at 12 months. |
Knäskada och osteoartrir score (KOOS) efter 12 månader och en kombination av RSA-variablerna efter 12 månader. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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LVLS |
Sista besöket av den sista patienten |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |