Additional identifiers
EudraCT number
2010-020973-18
ClinicalTrials.gov number
Protocol/serial number
2010-020973-18
Study information
Scientific title
Effect of treatment with L0006CP on the time of fracture-healing: a prospective, multi-centre, double-blind, randomised, placebo controlled clinical trial
Acronym
L0006CP
Study hypothesis
To compare the effect of a treatment with ossein L0006CP compound versus a placebo on the time of fracture-healing in patients with a wrist fracture
Ethics approval
Not provided at time of registration.
Bioethical committee of Centre for Medical Education, Warsaw (Centrum Medyczne Kształcenia) - approval pending
Study design
Prospective multicentre double-blind randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Wrist fracture
Intervention
L0006CP film-coated tablets OR placebo tablets for 12 weeks (1 tablet twice a day)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Comparison between the two treatments, of the time to radiological healing in the two groups
Secondary outcome measures
Comparison between the two groups of:
1. Time to disappearance of fracture line
2. Time to full normal activity of daily living involving the target upper limb
3. Percentage of patients with at least one adverse event occurring under treatment
Overall trial start date
15/03/2011
Overall trial end date
15/10/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or menopausal female between 50 and 80 years of age
2. A recent closed Colles fracture, correctly reduced and stabilised
3. Willing, able to understand and sign an approved informed consent form
4. Able to understand the protocol and to come to the control visits
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Fractures not meeting inclusion criteria (including pathological fractures)
2. Previous or concomitant treatment that may influence recovery
3. Concomittant treatments interfering with bone metabolism
Recruitment start date
15/03/2011
Recruitment end date
15/10/2011
Locations
Countries of recruitment
Poland
Trial participating centre
Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny
Otwock
05-400
Poland
Funders
Funder type
Industry
Funder name
Pierre Fabre (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary