Protocol summary

Study aim
Determination of the effect of anti-osteoporosis drugs on osteoporotic fractures repair in hospitalized patients
Design
In this research, 75 eligible patients referring to Imam Khomeini Hospital of sari suffering from osteoporotic fracture were chosen purposefully and were randomly divided into three groups of control and intervention one and two by Table of random numbers.
Settings and conduct
This study was conducted at Imam Khomeini Hospital and among patients who entered the study according to inclusion criteria. Then, patients will be divided into three groups according to the random numbers table. The first group, after the surgery, received 1200 mg daily calcium, vitamin D 800 units and alendoronitis ; 70 mg / week for 3 months before being discharged from the hospital. The second group will be treated with calcium and vitamin D and the injectable parathyroid hormone branded synapar ;0.08 cc daily in the abdomen for 3 months. The third group of patients from patients admitted to the service of other orthopedic professors who receive only 1200 milligrams of calcium daily and vitamin D 800 units. Then they will be followed up after the discharge. After 1 month and 3 months, patients will be followed up by telephone over their medications and their acceptance capacity, as well as the side effects of drugs and the incidence of fracture. Patients will also be requested at week 4 and 8 and 12, and after surgery to check the amount of restoration of fracture by radiography. Also, in follow-up 3 months later, bone density measurement will be done at the same center by the same technician. . And if the patient situation does not improve, the patient's will continue the treatment according to bone Densimetry.
Participants/Inclusion and exclusion criteria
major inclusin and exclusion criteria: Patients Aged over 50 years, with a sudden fracture of the wrist, vertebra or hip with Tscore less than 2.5 - who have undergone a Corrective surgical procedure, and Do not take anti-osteoporosis drugs including bisphosphonate, calcitonin, raloxifene, and parathyroid hormone over the past 6 months before fracture were included; Patients who have Previous history of osteoporotic fractures, Multiple trauma, Cancer, Other diseases requiring aggressive, corticosteroid, or immunosuppressive therapy and Selective arthroplasty were excluded
Intervention groups
Intervention group one: 1200 mg daily calcium, vitamin D-800 units plus parathyroid hormone injections branded sinopar Intervention group two: daily 1200 mg calcium, vitamin D 800 units plus alendoronitis made with a dose of 70 mg Control group: daily calcium group 1200 mg, vitamin D 800 units
Main outcome variables
The rate of fracture restoration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160830029603N6
Registration date: 2018-01-24, 1396/11/04
Registration timing: registered_while_recruiting

Last update: 2018-01-24, 1396/11/04
Update count: 0
Registration date
2018-01-24, 1396/11/04
Registrant information
Name
Masoud Shayestehazar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3304 4859
Email address
shayestehazar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of anti-osteoporosis therapies on the repair of osteoporotic fractures in patientss admitted to the orthopedic ward
Public title
Comparison of the effect of anti-osteoporosis therapies on the repair of osteoporotic fractures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 50 years old Patients with a sudden fracture of the wrist, vertebra or hip with Tscore less than 2.5 - who have undergone a Corrective surgical procedure Do not take anti-osteoporosis drugs including bisphosphonate, calcitonin, raloxifene, and parathyroid hormone over the past 6 months before fracture
Exclusion criteria:
Previous history of osteoporotic fractures Multiple trauma Cancer Other diseases requiring aggressive, corticosteroid, or immunosuppressive therapy Selective arthroplasty
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Random by using Random NumbersTable
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq.
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Approval date
2016-10-31, 1395/08/10
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.95.2767

Health conditions studied

1

Description of health condition studied
Osteoporosis
ICD-10 code
M80
ICD-10 code description
Osteoporosis with current pathological fracture

Primary outcomes

1

Description
The rate of fracture restoration
Timepoint
the assessment of fracture restoration in weeks 4, 8 and 12 after surgery
Method of measurement
Radiography

Secondary outcomes

empty

Intervention groups

1

Description
ّFirst Intervention group: Calcium and Vitamin D with parathyroid hormone branded Sinopar
Category
Treatment - Drugs

2

Description
Second Intervention group: Calcium and Vitamin D with Alendoronite made at a dose of 70 milligrams
Category
Treatment - Drugs

3

Description
Control group: Calcium and Vitamin D
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Masoud Shayestehazar
Street address
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4001
Email
mshayestehazar@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Ahmad Ali Enayati
Street address
Deputy of Research and Technology of Mazandaran University of Medical Science, moalem Sq., Moalem St., Sari
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3337 7169
Email
mshayestehazar@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Saber Joor Ebrahimian
Position
orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Fax
Email
shayestehazar@mazums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Masoud Shayesteh Azar
Position
Hip Surgery Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Fax
Email
shayestehazar@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Saber Joor Ebrahimian
Position
orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Fax
Email
shayestehazar@mazums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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