Protocol summary

Summary
The purpose of the present study is to investigate the potential effect of vitamin K on the Bone mineral density of patients with postmenopausal osteoporosis. This open, randomized, parallel study will be conducted on patients with osteoporosis according to WHO Criteria (T≤ -2.5) 2) who will attend to the rheumatology clinic of Imam Reza Hospital, Mashhad, Iran. Eligible patients are those who meet all the following criteria: 1) Osteoporosis according to WHO Criteria (T≤ -2.5) 2) Age: 45-65 years 3) postmenopausal women. Patients are not eligible if they have: 1) secondary osteoporosis 2) Taking anticoagulants 3) History of liver and kidney disorders 4) History of bisphosphonates side effects 5) People who have contraindications to take calcium and vitamin D 6) People who take other anti- osteoporotic medications and 7) People who needs to use Vitamin K in the group 1. The total number of patients will be fifty cases. The patients will randomly assign into two groups: group 1 (n=25) will receive calcium + vitamin D pills twice daily (Jalinous company, Tehran, Iran, each pill has 500 mg calcium and 200 IU vitamin D), 70 mg Alendronate orally per week (Alenate®; Dr. Abidi Company, Tehran, Iran). Group 2 (n=25) will receive the same combination plus vitamin K1 pills 10 mg daily (Pars Minoo Ind. Company, Tehran, Iran). The duration of treatment will be one year in both groups. The main outcome measure will be bone mineral density. At the end of the study, we will measure bone mineral density again for all of the patients by the same scanner.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504141479N3
Registration date: 2015-08-17, 1394/05/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-17, 1394/05/26
Registrant information
Name
Mohammadhassan Jokar
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 8818
Email address
jokarmh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice president of Mashhad University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of alendronate and Vitamin K Combination versus Alendronate alone on bone mineral density of patients with postmenopausal osteoporosis
Public title
The effects of alendronate and Vitamin K on postmenopausal osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Osteoporosis according to WHO Criteria 2-Age:45-65 years 3- Postmenopausal women Exclusion criteria 1- Secondary Osteoporosis 2- Taking anticoagulants 3- History of liver and kidney disorders 4- History of Bisphosphonates side effects 5- People who have contraindications to take calcium and vitamin D 6- People who take other anti- osteoporotic medications 7- People who needs to use Vit.K in the alendronate group
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: via a random number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical sciences, Daneshgah street
City
Mashhad
Postal code
9177899191
Approval date
2012-08-11, 1391/05/21
Ethics committee reference number
IR.MUMS.REC.1391.101

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 mineral density
Timepoint
Before the intervention and one year later
Method of measurement
By Densitometery with DXA method

Secondary outcomes

1

Description
Drug side effects
Timepoint
Every 2 months
Method of measurement
Taking history

Intervention groups

1

Description
Group 1 will receive calcium + vitamin D pills twice daily (Jalinous company, Tehran, Iran, each pill contains 500 mg calcium carbonate and 200 IU vitamin D) and 70mg alendronate orally per week (Alenate®; Dr. Abidi Company, Tehran, Iran). The duration of treatment will be one year.
Category
Treatment - Drugs

2

Description
Group 2 will receive calcium + vitamin D pills twice daily (Jalinous company, Tehran, Iran, each pill contains 500 mg calcium carbonate and 200 IU vitamin D), 70mg alendronate orally per week (Alenate®; Dr. Abidi Company, Tehran, Iran) and vitamin K1 pills 10 mg daily (Pars Minoo Ind. Company, Tehran, Iran). The duration of treatment will be one year.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammad Hassan Jokar
Street address
Chamran street
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice president for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Daneshgah street
City
Mshhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice president for research, Mashhad 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
Imam Reza Hospital
Full name of responsible person
Mohammad Hassan Jokar
Position
MD, Rheumatologist, Associated Professor
Other areas of specialty/work
Street address
Internal medicine ward, Imam Reza Hospital, Chamran street
City
Mashhad
Postal code
9177899191
Phone
+98 51 3859 8818
Fax
+98 51 3859 8818
Email
jokarmh@mums.ac.ir
Web page address
http://my.mums.ac.ir/default.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mohammad Hassan Jokar
Position
Rheumatologist, Associated Professor
Other areas of specialty/work
Street address
Chamran street
City
Mashhad
Postal code
9177899191
Phone
+98 51 3859 8818
Fax
+98 51 3859 8818
Email
jokarmh@mums.ac.ir
Web page address
http://my.mums.ac.ir/default.aspx

Person responsible for updating data

Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mohammad Hassan Jokar
Position
Associated professor
Other areas of specialty/work
Street address
Chamran street
City
Mashhad
Postal code
9177899191
Phone
+98 518598818
Fax
+98 15 8591 8818
Email
Jokarmh@mums.ac.ir
Web page address
http://my.mums.ac.ir/default.aspx

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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