The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000876998
Ethics application status
Approved
Date submitted
10/08/2011
Date registered
17/08/2011
Date last updated
18/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
To study the efficacy of strontium ranelate on the healing of surgically fixed diaphyseal tibial fractures and compare it to placebo
Scientific title
Efficacy of Strontium Ranelate versus placebo on time to fracture healing of tibial fractures in adults
Secondary ID [1] 262815 0
Nil
Universal Trial Number (UTN)
U1111-1123-2867
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fracture healing 270533 0
Condition category
Condition code
Injuries and Accidents 270694 270694 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to study the efficacy of strontium ranelate in the dose of 2gm daily on the healing of surgically fixed diaphyseal tibial fractures and compare it to placebo. The subjects will receive strontium ranelate for a period of 3months commencing from the 1st day after fracture fixation. Strontium ranelate will be administered in an oral suspension form with yellow granules in a sachet to be mixed in 30ml water.
Intervention code [1] 269162 0
Treatment: Drugs
Comparator / control treatment
Placebo, packed in identical sachets containing yellow placebo granules to be mixed in 30ml of water and to be administer in an oral suspension form.
Control group
Placebo

Outcomes
Primary outcome [1] 269406 0
X rays will be done after fixation of fracture and then monthly for signs of fracture healing
Timepoint [1] 269406 0
immedate post operative and then monthly for total 3months
Primary outcome [2] 269407 0
All patients will be assessed at end of 3 months by independent observers (Orthopedic Surgeon and a radiologist) for fracture healing
Standard criteria, clinical as well as radiological will be used to assess the patients.
Timepoint [2] 269407 0
End of 3months from date of surgery
Secondary outcome [1] 287575 0
Levels of P1NP will be measured at time of enrollment and at 3 months and correlated with efficacy of fracture healing. This is a serum essay.
Timepoint [1] 287575 0
at time of enrollment and end of 3months from date of surgery

Eligibility
Key inclusion criteria
All adult patients between 18 and 60 years of age presenting with closed diaphysial tibial fractures, amenable to fixation with a Dynamic Compression Plate / Locking Compression Plate
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All open fractures
Patients under 18 yrs or over 60 yrs
Metaphyseal /periarticular fractures
Patients with previous procedures in that limb
Fractures requiring bone grafting
Pregnant patients
Patients with renal impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients meeting eligibility criteria will be randomized in a double blind fashion to receive either the study drug (strontium ranelate in a dose of 2gm daily in sachet form) or a placebo for 3 months.
Patients have been divided into Groups A and B to receive identical appearing pre-labeled and pre-packed medication boxes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
consecutive alternate sampling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3778 0
Pakistan
State/province [1] 3778 0
Sindh

Funding & Sponsors
Funding source category [1] 269639 0
Commercial sector/Industry
Name [1] 269639 0
Pharmevo (Pvt.) Ltd.
Address [1] 269639 0
402-Business Avenue
Block 6, P.E.C.H.S.
Shahrah-e-Faisal
Karachi. 75400
Country [1] 269639 0
Pakistan
Primary sponsor type
Commercial sector/Industry
Name
Pharmevo (Pvt.) Ltd.
Address
402-Business Avenue
Block 6, P.E.C.H.S.
Shahrah-e-Faisal
Karachi. 75400
Country
Pakistan
Secondary sponsor category [1] 266671 0
Hospital
Name [1] 266671 0
The Indus Hospital
Address [1] 266671 0
The Indus Hospital
Korangi Crossing
Korangi
Karachi. 75190
Country [1] 266671 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269584 0
IRD IRB
Ethics committee address [1] 269584 0
Head Office
Suite 508, Ibrahim Trade Tower
Main Sharah-e-Faisal
Karachi, 75350
Ethics committee country [1] 269584 0
Pakistan
Date submitted for ethics approval [1] 269584 0
Approval date [1] 269584 0
05/08/2011
Ethics approval number [1] 269584 0
IRD_IRB_2011_7_005

Summary
Brief summary
Strontium Ranelate is approved for treatment of osteoporosis. Its mode of action is thought to be a combination of anti resorptive and anabolic on bone. The bone forming ability has been documented in animal studies as well as in the increase in level of P1NP (A bone formation marker).
There are anecdotal reports that it enhances fracture healing in humans but very little prospective data is present. The purpose of this study is to study the efficacy of strontium ranelate in the dose of 2gm daily on the healing of surgically fixed diaphyseal tibial fractures and compare it to placebo.
Trial website
Trial related presentations / publications
Presented Prospective Study in 27th International Pak-Orthocon (Findings Answers-Improving Lives) 21st Nov 2013 till 24th Nov 2013: Significance of P1NP Values In Assessment Of healing of surgically fixed Tibial Diaphyseal fractures treated with Strontium Ranelate V/S Placebo: A Randomised Double Blind Placebo control clinical Trial.
Poster Presentation in ICON (Indus Hospital Conference) 25 Jan 2014: Significance of P1NP Values In Assessment Of healing of surgically fixed Tibial Diaphyseal fractures treated with Strontium Ranelate V/S Placebo: A Randomised Double Blind Placebo control clinical Trial.
Free paper “Significance Of P1NP Values In Assessment Of Fracture Healing Of Surgically Fixed Tibial Diapyseal Fractures Treated With Strontium Ranelate Vs Placebo; A Randomized Double Blind Controlled Trial”----15th EFORT Congress in London from 4 - 6 June 2014.
Public notes

Contacts
Principal investigator
Name 33001 0
Dr Muhammad Zeeshan Aslam
Address 33001 0
Department Of Orthopaedics The Indus Hospital Korangi Crossing Korangi Karachi. 75190
Country 33001 0
Pakistan
Phone 33001 0
+92-300-2322811
Fax 33001 0
+92-21-35112718
Email 33001 0
zeeshan_aslam_pk@yahoo.com
Contact person for public queries
Name 16248 0
Dr Dr. M. Zeeshan Aslam
Address 16248 0
Department Of Orthopaedics
The Indus Hospital
Korangi Crossing
Korangi
Karachi. 75190
Country 16248 0
Pakistan
Phone 16248 0
+92-300-2322811
Fax 16248 0
+92-21-35112718
Email 16248 0
zeeshan_aslam_pk@yahoo.com
Contact person for scientific queries
Name 7176 0
Dr Dr. Mansoor Ali Khan
Address 7176 0
Department Of Orthopaedics
The Indus Hospital
Korangi Crossing
Korangi
Karachi. 75190
Country 7176 0
Pakistan
Phone 7176 0
+92-300-8202537
Fax 7176 0
+92-21-35112718
Email 7176 0
makbonedoc65@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary