E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061959 |
E.1.2 | Term | Fracture treatment |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 main objective of this study is to compare the effect of a treatment with ossein-hydroxyapatite compound (L0006CP) versus a placebo on the time of fracture-healing in patients with a wrist fracture. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are:
- To assess the effect of the L0006CP on :
- the functional improvement of upper limb,
- the reduction of the time of return to normal function,
- To evaluate safety and tolerability of L0006CP.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be included in the trial, patients should fulfill the following criteria:
- male or menopausal female between 50 and 80 years of age,
- a recent closed Colles’ fracture (< 48 hours ), correctly reduced and stabilised with Kirschner wires,
- willing, able to understand and sign an approved Informed Consent Form,
- able to understand the protocol and to come to the control visits,
- registered with a social security or health insurance system (if applicable).
|
|
E.4 | Principal exclusion criteria |
Patients fulfilling at least one of the following criteria cannot be included in the study:
- a criterion connected to pathologies:
- Patient with an open fracture,
- Patient with a bilateral Colles’ fracture or multiple concurrent fractures or injuries,
- Patient with fracture which may require a surgical treatment during the study treatment,
- Patient having had a fracture of the upper limb or a prolonged immobilization during the 12 months preceding the inclusion,
- Patient having had a functional impairment of the hand or the forearm before injury,
- Patient with a pathological fractures related to cancer,
- Patient with hereditary bone disease,
- Patient with bone necrosis,
- Patient with chronic renal failure or chronic kidney disease or history of renal calculi,
- Patient with history of calcium metabolism disorders (hypercalcemia, hypocalcemia…),
- a criterion connected to previous or concomitant treatment:
- Patient receiving or have received treatment by chemotherapy, radiotherapy, immunosuppressive or systemic steroid treatment within 6 months prior to the inclusion visit,
- Patient receiving or expected to receive during the course of the study any medication (other than study medication) which might alter bone metabolism: Calcium and phosphate preparations, calcitonin, hormone replacement therapy, anabolic agents, parathormone, heparins (long term treatment), barbiturates, hydantoin, insulin, thiazides,
- Patient with a known allergy to the study medication or one of its constituents,
- Patient requiring regular or intermittent steroid therapy.
- a criterion connected to the study population:
- Patient with a body mass index (BMI) greater than 34,
- Patient with generalized rheumatic disease (rheumatoid arthritis, osteoarthritis…) which could impair severely the joint function of the upper limbs,
- Patient with concomitant disease known to delay the time of frature-healing such as diabetes, respiratory insufficiency, anaemia, vascular insufficiency, thrombophlebitis….
- Patient with an inflammatory bowel disease or any digestive disease which could modify calcium absorption,
- Patient with known history of lactose intolerance, hereditary galactose intolerance, the Lapp lactase deficiency or glucose / galactose malabsorption
- Patient with a severe acute or chronic disease which the investigator deems incompatible with study implementation,
- Patient with a disease which the investigator considers likely to interfere with the study results or to expose the patient to additional risk,
- Patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion,
- Patient having taken part in a clinical trial in the preceding 30 days or taking part in a trial at the time of inclusion,
- Patient linguistically or psychologically unable to understand and sign the consent form,
- Patient who has forfeited his freedom by administrative or legal award, or who is under guardianship.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary criterion will be the comparison between the 2 treatments of the time to cortical bridging of three cortices in the 2 groups. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 4, Week 6, Week 7 , Week 8, Week 10 and Week 12. |
|
E.5.2 | Secondary end point(s) |
Time to cortical bridging of 2 and 4 cortices.
Time to disappearance of fracture line. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4, Week 6, Week 7 , Week 8, Week 10 and Week 12. |
|
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 | 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 | 9 |
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
|
The last visit of the last subject undergoing the trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 14 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 14 |
E.8.9.2 | In all countries concerned by the trial days | 0 |