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Assessment of the effect of Padzahr tablet on the turnover of bone formation in postmenopausal osteopenic women: A Randomized Double-Blind Placebo-Controlled Trial

Protocol summary

Study aim
Determination of the effectiveness of Padzahr tablet on the turnover of bone formation in postmenopausal osteopenic women
Design
Participants will be selected based on inclusion and exclusion criteria and divided into 2 groups, randomized, in the order of admission. Every group, based on the age, will be divided into 4 subgroups, 40-55, 50-55, 55-60 and 60-65. The first one of the similar age groups, will recieve drug A and drug B will be given the second one and the others, by turns, will recieve drug A or drug B. Intervention group will be ordered Padzahr tablet, 6 tablets daily, divided in 3 doses and control group will be ordered placebo tablet, the same way.
Settings and conduct
This research will be done in Akbarabadi hospital. Participants will be selected based on inclusion and exclusion criteria and divided into 2 groups, randomized, in the order of admission and every group, based on the age, will be divided into 4 subgroups. In order to assessment of the bone formation and bone resorption factors, blood sampling will be done, at the begining of the study and after 3 months.
Participants/Inclusion and exclusion criteria
Osteopenic women Greater than 45 and under 65 years of age Osteopenia, based on WHO definition: T Score between -2.5 and -1 No history of allergy and anaphylaxis
Intervention groups
Intervention group: Osteopenic postmenopausal women, will be ordered Padzahr tablet: 6 tablets daily, divided in 3 doses. Control group: Osteopenic postmenopausal women, will be ordered placebo tablet: 6 tablets daily, divided in 3 doses.
Main outcome variables
OC BAP P1NP CTX-1

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180710040406N1
Registration date: 2018-12-02, 1397/09/11
Registration timing: registered_while_recruiting

Last update: 2018-12-02, 1397/09/11
Update count: 0
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Shabnam Rafiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4476 2837
Email address
sh-rafiee@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Padzahr tablet on the turnover of bone formation in postmenopausal osteopenic women: A Randomized Double-Blind Placebo-Controlled Trial
Public title
The effect of Padzahr tablet on Osteopenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Osteopenic postmenopausal women Greater than 45 and under 65 years of age Osteopenia, based on WHO definition: T Score between -2.5 and -1 No history of allergy and anaphylaxis
Exclusion criteria:
Use of Tobacco products, Alcohol and narcotic products History of choronic diseases, including Cancer, Cardiovascular diseases, Diabetes mellitus, Renal failure, Liver diseases, Systemic inflammatory diseases, Degenerative joint diseases, Rheumatologic disorders, Thalassemia, Primary hyperparathyroidism, Hyperthyroidism, Cushing's syndrome, Hypercalciuria, Hypogonadism Gastrointestinal diseases, including Crohn's disease, Ulcerative colitis, Celiac, Choronic diarrhea, under treatment gastric or duodenal ulcer, history of gastrointestinal bleeding History of drug consumption, affecting bone metabolism like Osteoporosis drugs , Diuretics, Thiazides, Anti convulsive drugs, Glucocorticoides and NSAIDES Motor disability and skeletal disorders except Osteopenia Untreated psychologic or neurologic diseases like Psychosis, Alzheimer and Parkinson Diseases History of bone diseases No tendency for randomization
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be selected based on inclusion and exclusion criteria and divided into 2 groups, randomized, in the order of admission. Every group, based on the age, will be divided into 4 subgroups, 40-55, 50-55, 55-60 and 60-65. The first one of the same age groups, will receive drug A and drug B will be given the second one and the others, by turns, will receive drug A or drug B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug and placebo will have codes and participants, Principal researcher, medical personnel, data collection authorities and statistical analyzer will not have information about drug and placebo groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 27, Northen Sarparast street, West Taleghani Ave., Felestin square
City
Tehran
Province
Tehran
Postal code
1416663361
Approval date
2018-09-13, 1397/06/22
Ethics committee reference number
IR.TUMS.VCR.REC.1397.422

Health conditions studied

1

Description of health condition studied
Osteopenia
ICD-10 code
M81.0
ICD-10 code description
Age-related osteoporosis without current pathological fracture

Primary outcomes

1

Description
Turnover of bone formation based on Laboratory tests
Timepoint
Baseline and after 3 months
Method of measurement
ELISA laboratory tests

Secondary outcomes

1

Description
Plasma Osteocalcin (OC)
Timepoint
At the beginning of the study and 3 months after start of drug using
Method of measurement
Elisa Test

2

Description
Plasma Bone Alkaline Phosphatase (BAP)
Timepoint
At the beginning of the study and 3 months after start of drug using
Method of measurement
Elisa Test

3

Description
Plasma Procollagen Type 1 N-Terminal Propeptide (P1NP)
Timepoint
At the beginning of the study and 3 months after start of drug using
Method of measurement
Elisa Test

4

Description
Plasma C-terminal telopeptide (carboxy-terminal collagen crosslinks) (CTX)
Timepoint
At the beginning of the study and 3 months after start of drug using
Method of measurement
Elisa Test

Intervention groups

1

Description
Intervention group: Osteopenic postmenopausal women, will be ordered Padzahr tablet: 6 tablets daily, divided in 3 doses.
Category
Treatment - Drugs

2

Description
Control group: Osteopenic postmenopausal women, will be ordered placebo tablet: 6 tablets daily, divided in 3 doses.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbarabadi hospital
Full name of responsible person
Shabnam Rafiee
Street address
Molavi avenue
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Fax
+98 21 5560 8012
Email
akbarabadihosp@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Niak company
Full name of responsible person
Dr. Hooman Bayat
Street address
Pasdaran Avenue
City
Gorgan
Province
Golestan
Postal code
49175/596
Phone
+98 17 3451 6192
Fax
+98 17 3451 6194
Email
Niak.pharmaceutical@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Niak company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shabnam Rafiee
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, Northen Sarparast street, West Taleghani Ave., Felestin square
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4535
Email
Shara_514@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shabnam Rafiee
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, Northen Sarparast street, West Taleghani Ave., Felestin square
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4535
Email
Shara_514@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shabnam Rafiee
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, Northen Sarparast street, West Taleghani Ave., Felestin square
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4535
Email
Shara_514@yahoo.com

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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