Effect of treatment with L0006CP on the time of fracture-healing

ISRCTN	ISRCTN71678602
DOI	https://doi.org/10.1186/ISRCTN71678602
EudraCT/CTIS number	2010-020973-18
Secondary identifying numbers	2010-020973-18

Submission date: 23/02/2011
Registration date: 07/04/2011
Last edited: 20/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stanislaw Pomianowskip
Scientific

Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny
im. Prof. Adama Grucy
ul. Konarskiego 13
Otwock
05-400
Poland

Study information

Study design	Prospective multicentre double-blind randomised placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of treatment with L0006CP on the time of fracture-healing: a prospective, multi-centre, double-blind, randomised, placebo controlled clinical trial
Study acronym	L0006CP
Study objectives	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(s)	Not provided at time of registration. Bioethical committee of Centre for Medical Education, Warsaw (Centrum Medyczne Kształcenia) - approval pending
Health condition(s) or problem(s) studied	Wrist fracture
Intervention	L0006CP film-coated tablets OR placebo tablets for 12 weeks (1 tablet twice a day)
Intervention type	Other
Primary outcome measure	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 study start date	15/03/2011
Completion date	15/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	90
Total final enrolment	58
Key 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
Key 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
Date of first enrolment	15/03/2011
Date of final enrolment	15/10/2011

Locations

Countries of recruitment

Poland

Study participating centre

Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny

Otwock
05-400
Poland

Sponsor information

Pierre Fabre (France)
Industry

Canceropole
3 Avenue Hubert Curien
BP13562
Toulouse Cedex
31035
France

"ROR"	https://ror.org/04hdhz511

Funders

Funder type

Industry

Pierre Fabre (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			20/05/2019	No	No

Editorial Notes

The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.