The aim of this study is evaluation of the effect of Calcium -Vitamin D and Alendronate on serum Dickkopf-1( Dkk-1) and Osteoprotegerin(OPG) in women with osteoporosis.Study will be done without placebo.The study population includes menopause women reffered to specialty clinics of Tabriz University of Medical Sciences.Sample size in this study is 72 people.36 people with normal bone density is intended to determine the relation of serum levels of OPG and Dkk-1 with bone density in women with osteoporosis and without osteoporosis. 36 people with osteoporosis are intervention group. Inclusion criteria for intervention: menopause women that on the basis of the results obtained in densitometry according to the WHO criteria,have osteoporosis (Tscore below -2.5)at least in one of the two site(hip and spine).Exclusion criteria:Use of glococorticoids and medications that affect bone metabolism and density ,previous treatment with calcium or vit D or both,osteoporosis secondary to disease,history of malignant disease and presence of advanced osteoarthritis in physical examination.Women with osteoporosis will be treat with Calcium-Vit D 1000 mg daily and Alendronate 70 mg once a week for 4 months,prior to initiating therapy and 4 months later serum levels of OPG and Dkk-1 will be evaluate. The primary outcome measures are serum levels of Dickkopf-1 and Osteoprotegerin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201238809N1
Registration date:2012-03-01, 1390/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-01, 1390/12/11
Registrant information
Name
Bahareh Amanifar
Name of organization / entity
tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3966
Email address
amanifarb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Calcium -Vitamin D and Alendronate on serum Dickkopf-1( Dkk-1) and Osteoprotegerin(OPG) in women with osteoporosis
Public title
Effect of Calcium -Vitamin D and Alendronate on serum Dickkopf-1( Dkk-1) and Osteoprotegerin(OPG) in women with osteoporosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1.Menopause women that on the basis of the results obtained in densitometry according to the WHO criteria,have osteoporosis (Tscore below -2.5)at least in one of the two site(hip and spine).
Exclusion criteria:
1.Use of glucocorticoids or other medications that affect bone metabolism and density( cytotoxic drugs and anticoagulants).
2.Patients treated with Calcium or Vit D or both.
3.History of malignant disease.
4.Disease that cause secondary osteoporosis,such as intestinal,hepatic,hematologic,kidney disease;rheumatologic disease (such as RA,SLE) and endocrine disease (such as cushing syndrome,hypogonadism).
5.Presence of advanced osteoarthritis in physical examination.
Age
From 45 years old to 100 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics committee, Research vice chancellor, Faculty of medicine, Tabriz University of Medical Sciences