Evaluation the effect of cinoppar drug on the degree of welding and improvement of fracture with mild distal Radius trauma
Design
Clinical trial with control group, community based and pragmatic, with parallel groups, one-way blinded, randomized
Settings and conduct
This srudy will be conducted at Zahedan Khatam Al-Anbiya Hospital. In this study the doctor is aware of the type of treatment but the patients themselves will be unaware of the treatment group and therefore the study will be single blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 45 years; single fracture of distal radius with low energy; fracture requiring reduction and plating.
Exclusion criteria: fracture with displacement or surgical need; use of Cinnopar or its external model at the time of entry; fracture with high energy; use at least 4 weeks of bone resorption inhibitors such as bisphosphonates; history of chemotherapy or radiotherapy; history of urinary stones; hypercalcemia more than 10 mg per deciliter or hypercalciuria; developing advanced liver or kidney disorders; autoimmune diseases; smoking or drug abuse
Intervention groups
The control group will include 50 patients who will receive fracture treatment alone (reduction and plating). The intervention group is consisted of 50 patients who will receive Cinnopar (vial 250 μg/ml, manufactured by Sinagan Pharmaceutical Company), 20 micrograms subcutaneous injection daily in the morning for 8 weeks in addition to usual fracture treatment (reduction and plating). For all of the patients in the two groups, elemental calcium 1000 mg tablets will be prescribed daily and vitamin D 50,000 IUs capsules will be administered weekly.
Main outcome variables
Clinical improvement of fracture; Radiographic improvement of fracture (welding)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180526039837N1
Registration date:2018-06-06, 1397/03/16
Registration timing:registered_while_recruiting
Last update:2018-06-06, 1397/03/16
Update count:0
Registration date
2018-06-06, 1397/03/16
Registrant information
Name
maryam Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3322 7521
Email address
dr.ashrafi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cinnopar drug on the degree of healing and fracture union with mild distal radius trauma
Public title
Effect of Cinnopar on forearm fracture healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single radial distal fracture with low energy
Fractures require close reduction and plastering
Exclusion criteria:
Fracture with displacement or need of surgery
Fracture occurring with high energy
Administration of bone resorption inhibitors such as bisphosphonates for at least 4 weeks
History of chemotherapy or radiotherapy
History of urinary stones
Hypercalcemia more than 10 mg per deciliter or hypercalciuria
Advanced liver or kidney disorder
Autoimmune diseases
Smoking or drug abuse
Age
From 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
The doctor is aware of the type of treatment but the patients themselves are unaware of the type of treatment they will receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr.Hesabi Sq., Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.ZAUMS.REC.1395. 97
Health conditions studied
1
Description of health condition studied
Distal radius fracture
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
Clinical fracture improvement
Timepoint
Every two weeks for 8 weeks
Method of measurement
Based on an orthopedic physician examination, capability to get things, no movement restrictions, no pain
2
Description
Radiographic improvement of fracture(Welding)
Timepoint
Every two weeks for 8 weeks
Method of measurement
Based on radiological findings, bone formation and cortex stretching
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving fracture treatment (reduction and plating) and then administering Cinnopar(250 μg/ml vial, manufactured by Sinagan Pharmaceutical Company), subcutaneous injection of 20 micrograms daily in the morning for 8 weeks plus daily administration of 1000 Mg of elemental calcium tablets and weekly vitamin D capsules of up to 50,000 international units
Category
Treatment - Drugs
2
Description
Control group: receiving fracture treatment (reduction and plating) and then administration of 1000 Mg of elemental calcium tablets and weekly vitamin D capsules of up to 50,000 international units for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic Clinic of Khatam-ol-Anbia Hospital in Zahedan
Full name of responsible person
Dr. Arash Ghafari
Street address
Khatam Al Anbia Hospital, Jamejam Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
Dr.ghafari@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Mohsen Taheri
Street address
Zahedan University of Medical Sceinces, Dr. Hesabi Sq., Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
Dr.taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Ashrafi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ali-ebn Abi Talib Hospital, Salamat Blvd., Daneshgah Ave., Zahedan