Objectives: Evaluation of the effect of dynamic hyper extension brace on the reduction of kyphosis and osteoporosis in postmenopausal osteoporotic women.
Design: Randomized controlled trial.
Setting and conduct: A total of 60 postmenopausal osteoporotic women will be randomly assigned to the case and control group.
Inclusion criteria: Female; postmenopausal; osteoporosis; Kyphosis;
Exclusion criteria: Patients having metabolic or hormonal disorders affecting the skeletal structure; patients receiving drugs with known affect on bone metabolism; patients currently receiving osteoporosis treatment; patients not able to use brace;
Interventions: A 600000 unit intramuscular vitamin D and 35 mg/ week oral alendronate will be administered for control group. The case group was additionally intervened by the application of Dynamic hyper extension brace containing one kilogram weight, and asked to use the brace 12 hours a day in their daily activities .
Main outcome measures: osteoporosis; kyphosis.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016111430871N2
Registration date:2016-12-13, 1395/09/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-13, 1395/09/23
Registrant information
Name
Alireza Mirzaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2000
Email address
mirzaei.ar@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dynamic hyperextension brace on osteoporosis and kyphosis reduction in postmenopausal osteoporotic women
Public title
The effect of brace on osteoporosis and kyphosis reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female; postmenopausal; osteoporosis; Kyphosis;
Exclusion criteria: Patients having metabolic or hormonal disorders affecting the skeletal structure; patients receiving drugs with known affect on bone metabolism; patients currently receiving osteoporosis treatment; patients not able to use brace;
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be performed using table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Postal code
Approval date
2001-10-27, 1380/08/05
Ethics committee reference number
386/الف
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M81.0
ICD-10 code description
Postmenopausal osteoporosis
2
Description of health condition studied
Kyphosis
ICD-10 code
M40.0
ICD-10 code description
Postural kyphosis
Primary outcomes
1
Description
Osteoporosis
Timepoint
At the start of the study and one year after the start of the intervention
Method of measurement
Bone mineral density
2
Description
Kyphosis
Timepoint
At the start of the study and one year after the start of the intervention
Method of measurement
Ruler
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Case group: A 600000 unit intramuscular vitamin D will be administered. A dose of 35 mg/ week oral Alendronate (Ostomeod, Modava Company, Iran) will also be administered as the osteoporosis drug of choice. Additionally, the case group will be intervened by the application of a Dynamic Hypercompression Brace containing one kilogram weight, and asked to use the brace 12 hours a day in their daily activities.
Category
Treatment - Devices
2
Description
Control group: A 600000 unit intramuscular vitamin D will be administered. A dose of 35 mg/ week oral Alendronate (Ostomeod, Modava Company, Iran) will also be administered as the osteoporosis drug of choice.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bone and Joint Reconstruction Research center
Full name of responsible person
Alireza Mirzaei
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Naserbakht
Street address
Iran University of Medical Sciences, Shahi Hemmat Highway,
City
Tehran
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, Iran 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
Bone & Joint Reconstraction Research Center
Full name of responsible person
Alireza Mirzaei
Position
Assistant Professor/ PhD
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Sq
City
Tehran
Postal code
Phone
+98 21 3354 2000
Fax
Email
mirzaeialireza26@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bone & Joint Reconstruction Research Center
Full name of responsible person
Alireza Mirzaei
Position
P.hD
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Sq
City
Tehran
Postal code
Phone
+98 21 3354 2000
Fax
Email
mirzaeialireza26@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bone & Joint Reconstruction Research Center
Full name of responsible person
Alireza Mirzaei
Position
Assisstant professor/ PhD
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Sq
City
Tehran
Postal code
Phone
+98 21 3354 2000
Fax
Email
mirzaeialireza26@gmail.cvom
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)