Effect of treatment with ossein-hydroxyapatite compound on the time of fracture-healing.

• Conditions: Wrist fracture; MedDRA version: 14.0Level: PTClassification code 10061959Term: Fracture treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-020973-18-PL
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-27
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified