The aim of this study is to investigate the effects of Curcumin in combination with Alendronate on bone loss and bone turnover markers in Post Menopausal women’s with Osteoporosis. This study conducted is a double blind clinical trial. Inclusion criteria: Age between 55- 65 years, At least 5 years after the last menstrual period and Osteoporosis. Exclusion criteria: any secondary cause of osteoporosis such as metabolic or endocrine disease, affecting bone drugs such as Bisphosphonates, Calcium and Vitamin D, Cardiovascular, Cereberovascular, Rheumatologic disease, Alcohol and or smoking . Patients divided into four groups: control, Curcumin, Curcumin + Alendronate and Alendronate. Curcumin at a dose 110 mg daily and Alendronate at a dose of 5 mg per kg per day prescribed for 12 months, level of biochemical markers related to bone turnover and also densitometry features of patients were performed for all patients at baseline and 12 months after the intervention. Statistical analysis was performed end-to interpret result.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030424308N1
Registration date:2016-12-04, 1395/09/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-04, 1395/09/14
Registrant information
Name
Mohammad Reza Hafezi Ahmadi
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 2075
Email address
hafezi-m@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Curcumin on Bone Turnover markers and Bone Densitometry characteristics in Post Menopausal Women with Osteoporosis
Public title
The effect of Curcumin on Osteoporosis in Post Menopausal Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 55- 65 years, At least 5 years after the last menstrual period and Osteoporosis.
Exclusion criteria: any secondary cause of osteoporosis such as metabolic or endocrine disease, affecting bone drugs such as Bisphosphonates, Calcium and Vitamin D, Cardiovascular, Cereberovascular, Rheumatologic disease, Alcohol and or smoking
Age
From 55 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Sceince
Street address
Iran, Ilam, Ilam University of Medical Science, Banganjab, Daneshjoo boulevard
City
Ilam
Postal code
Approval date
2016-04-25, 1395/02/06
Ethics committee reference number
ir.medilam.rec.1395.187
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M81.0
ICD-10 code description
Postmenopausal osteoporosis
Primary outcomes
1
Description
Bone-specific alkaline phosphatase
Timepoint
Baseline and after 12 months
Method of measurement
laboratory kit
2
Description
Osteocalcin
Timepoint
Baseline and after 12 months
Method of measurement
laboratory kit
3
Description
Type 1 of Telopeptides
Timepoint
Baseline and after 12 months
Method of measurement
laboratory kit
4
Description
Femoral Neck Bone Mineral Density
Timepoint
Baseline and after 12 months
Method of measurement
laboratory kit
5
Description
Total Hip Bone Mineral Density
Timepoint
Baseline and after 12 months
Method of measurement
laboratory kit
6
Description
Lumbar Spine Bone Mineral Density
Timepoint
Baseline and after 12 months
Method of measurement
laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Control group :
No intervention
Category
Treatment - Drugs
2
Description
Alendronate groups:
Alendronate is administered at a dose of 5 mg/kg of body weight per day for 12 months .
Category
Treatment - Drugs
3
Description
Alendronate + curcumin group: alendronate at a dose of 5 mg/kg of body weight per day for 12 months + curcumin at a dose of 110 mg/kg of body weight per day for 12 months
Category
Treatment - Drugs
4
Description
Curcumin group: curcumin at a dose of 110 mg/kg of body weight per day for 12 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology and Obstetrics Clinic of Mostafa Khomeini in Ilam city
Full name of responsible person
Mohammad Reza Hafezi Ahmadi
Street address
Ilam University of Medical Sciences, Research Blvd, Ban Ganjab, Ilam city, Ilam Province, Iran
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Kourosh Sayemiri
Street address
Ilam University of Medical Sciences, Research Blvd, Ban Ganjab, Ilam city, Ilam Province, Iran
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Mohammad Reza Hafezi Ahmadi
Position
Pathologist
Other areas of specialty/work
Street address
Ilam University of Medical Sciences, Research Blvd, Ban Ganjab, Ilam city, Ilam Province, Iran
City
Ilam
Postal code
Phone
+98 84 2333 2132
Fax
Email
reza.ahmadi56@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Fatemeh Khanizadeh
Position
Obstetricians
Other areas of specialty/work
Street address
Ilam University of Medical Sciences, Research Blvd, Ban Ganjab, Ilam city, Ilam Province, Iran
City
Ilam
Postal code
Phone
+98 84 2333 2132
Fax
Email
fatemeh.khanizadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Fatemeh Khanizadeh
Position
Obstetricians
Other areas of specialty/work
Street address
Ilam University of Medical Sciences, Research Blvd, Ban Ganjab, Ilam city, Ilam Province, Iran
City
Ilam
Postal code
Phone
+98 84 2333 2132
Fax
Email
fatemeh.khanizadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)