Wrist fracture MedDRA version: 14.0 Level: PT Classification code 10061959 Term: Fracture treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: OSTEOGENON
Product Name: OSTEOGENON
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ossein hydroxyapatite compound
Current Sponsor code: L0006
Concentration unit: mg milligra
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;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.;Timepoint(s) of evaluation of this end point: Week 4, Week 6, Week 7 , Week 8, Week 10 and Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to cortical bridging of 2 and 4 cortices. Time to disappearance of fracture line.;Timepoint(s) of evaluation of this end point: Week 4, Week 6, Week 7 , Week 8, Week 10 and Week 12. | — |
Countries
Poland
Contacts
Public ContactAnne Maret
PIERRE FABRE MEDICAMENT
Outcome results
None listed