E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoporotic humerus fracture - accelerated fracture repair |
Osteoporotische Oberarmfraktur - Beschleunigung der Frakturheilung |
|
E.1.1.1 | Medical condition in easily understood language |
Osteoporosis |
Osteoporose - Knochenbuchkrankheit |
|
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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031288 |
E.1.2 | Term | Osteoporosis with fracture |
E.1.2 | System Organ Class | 100000004859 |
|
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 |
The primary objective is the quantitative assessment of fracture healing in treatment and placebo groups based on CT data and computational analysis of the bone structure. Bone structure will be assessed by means of quantized bone texture characteristics in the vicinity of the fracture. |
Evaluation der Frakturheilung mittels Computertomographie und Analyse der Knochenstruktur |
|
E.2.2 | Secondary objectives of the trial |
1. Detection and quantification of changes in bone mineralization at the fracture site between a baseline CT scan and a follow-up scan (planned interval: 12 weeks) using 3-D texture-based cluster analysis.
2. Evaluation of bone strength variation in the proximal humerus and the prediction of biomechanical properties (stiffness, strength, damage) based on the Finite Element (FE) technique
3. Baseline characterization of osteoporotic study population
4. Evaluation of fasting bone formation and resorption markers at baseline and after 3 months follow up
5. Assessment of quality of life improvement for TPTD and placebo groups with EQ-5D questionnaire
6. Assessment of pain reduction in TPTD and placebo groups by visual analog scale (VAS)
7. Assessment of functional testing after 3 and 6 months
8. DXA measurements of lumbar spine including early changes of geometrical parameters (CSA, CSMI, FSI), hip and total body (lean mass, fat mass, total body BMD)
|
Evaluation der Knochenstärke und Festigkeit und des Knochenstoffwechsels |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• recent proximal 2-segment humerus fracture (0-8 days post fracture)
• no surgical treatment at fractured site
• informed consent
• postmenopausal female and male patients aged 60 – 85 years
• established osteoporosis as defined by BMD measured with DXA-technology with a T-score ≤ -2.0 spine or hip
|
rezente proximale 2-Segment Humerusfraktur, Frauen und Männer 60 - 85 Jahre |
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E.4 | Principal exclusion criteria |
• any contraindication against teriparatide (TPTD, rhPTH 1-34)
o Hypersensitivity to the active substance or to any of the excipients.
o Pre-existing hypercalcemia
o Severe renal impairment (eGFR< 35ml/min)
o Metabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
o Unexplained elevations of alkaline phosphatase
o Prior external beam or implant radiation therapy to the skeleton
o Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
• any prior antiresorptive therapy (oral/intravenous bisphosphonates, RANKL-antibody, SERMs)
• any prior strontium ranelate therapy
• any prior TPTD of PTH 1-84 therapy
• malignancies ≤ 5 years except basalioma
• hypo-/hypercalcemia
• baseline 25-OH vitamin D3 level ≤10 ng/ml
• prosthesis at fractured and contralateral humerus
|
Kontraindikation gegen Forsteo gem.Fachinformation
Vorbehandlung mit einer osteologischen Therapie |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Acceleration of fracture repair and enhnaced biomechanical bone quality |
Beschleunigung der Frakturheilung und Verbesserung der biomechanischen Eigenschaften des Knochens |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 12 weeks |
nach 12 Wochen |
|
E.5.2 | Secondary end point(s) |
Increased trabecular and cortical bone texture mapping and finite elemente analysis |
Verbesserung kortikaler und trabekulärer Knochenstrukturen |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 12 weeks |
nach 12 Wochen |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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
| 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
|
LVLS |
letzte Patientenvisite |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |