The purpose of this study is to examine the effect of the injectable Cinnopar on the process of sickness , the rate of fractures, bone density, calcium level and serum phosphor in postmenopausal women with osteoporosis.
Design:This study is a singel blinded clinical trial which will be conducted on postmenopausal women with osteoporosis in Imam khomeini hospital in Sari-Iran.
The sample size is computed to be 30 clients in each group according to previous studies, and 95% confidence level.
Methods and materials: Approval is obtained from the Mazandaran University of Medical Sciences. Patients are recruited into the study by means of a convenience sampling method, and then randomly divided into two groups of experimental and control. All data will be collected by one of the researchers involved in this study. If patients give consent to participate in the study, the socio-demographic data and clinical data will be first gathered by a questionnaire.
Then the samples by the orders of their entry to the experiment using Rand Between function in Excel software will be randomly assigned into intervention and control groups. Clinical data are recorded using a questionnaire, including bone densitometry before treatment and six months after treatment, serum levels of calcium, vitamin D, alkaline phosphatase and phosphorus before treatment and six months after treatment.
Inclusion criteria: Postmenopausal women (aged 45 to 75 years old) diagnosed with osteoporosis by densitometry via Dexa(dual energy Xray absorptiometry).
Exclusion criteria: Women with a history of taking corticosteroids or any other medications which cause osteoporosis.
Intervention:experimental group receive daily 8/0 unit hypodermic insulin syringe from Cinnopar for six month.and daily receive 1000mg calcium and 400 unit edible vitaminD tablets for six month.
control group daily receive 1000mg calcium and 400 unit edible vitaminD tablets for six month.
The main outcome variables:Bone density; serum calcium and phosphorus level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016083029603N1
Registration date:2017-06-03, 1396/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-03, 1396/03/13
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
Vice Chancellor for Research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cinnopar on bone density, serum phosphorus and calcium levels in postmenopausal women with osteoporosis
Public title
The effect of cinnopar (teriparatide) in post-menopausal women with osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Postmenopausal women (aged 45 to 75 years old) diagnosed with osteoporosis by densitometry via Dexa(dual energy Xray absorptiometry); who do not have any history of treatment for osteoporosis; and consent to participate in the study were recruited into the study.
Exclusion criteria: Women with a history of taking corticosteroids or any other medications which cause osteoporosis ; hyperparathyroidism.
Age
From 45 years old to 75 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Science
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moalem Sq., Moalem St., Sari
City
Sari
Postal code
Approval date
2016-03-15, 1394/12/25
Ethics committee reference number
IR.MAZUMS.REC.94-1752
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M80.0
ICD-10 code description
Osteoporosis in postmenopausal women
Primary outcomes
1
Description
bone density
Timepoint
Before treatment and six months after treatment
Method of measurement
densitometry test through Dexa(dual energy Xray absorptiometry
2
Description
serum levels of calcium
Timepoint
Before treatment and six months after treatment
Method of measurement
blood test
3
Description
phosphor level
Timepoint
Before treatment and six months after treatment
Method of measurement
blood test
Secondary outcomes
1
Description
Fractures
Timepoint
One year
Method of measurement
Radiography
Intervention groups
1
Description
experimental group receive daily 8/0 unit hypodermic insulin syringe from Cinnopar for six month.
and daily receive 1000mg calcium and 400 unit edible vitaminD tablets for six month
Category
Treatment - Drugs
2
Description
control group daily receive 1000mg calcium and 400 unit edible vitaminD tablets for six month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
University Hospitals of Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Masoud Shayesteh Azar
Street address
Emam Khomeini Hospital, Amir Mazandarani St., Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, 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
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Masoud Shayesteh Azar
Position
Hip Surgery Fellowship
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, First of Vali Asr Hwy., Joibar 3way, Emam Sq., Sari
City
Sari
Postal code
4815733971
Phone
+1 133377169
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
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq., Sari
City
Sari
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 Zeinab Andarkhora
Position
Other areas of specialty/work
Street address
Ema Khomeini Hospital, Amir Mazandarani St., Sari
City
Sari
Postal code
48166_33131
Phone
+98 11 3337 7169
Fax
Email
orthopedics@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)