Triple blind evaluation of the efficacy of oral calcium Hydroxy-apatite on postoperative pain and bone mineral density in patients after pertrochanteric fracture surgery
Comparison of the effectiveness of oral calcium hydroxyapatite with calcium carbonate in patients after pertrochanteric fracture fixation surgery
Design
A randomized, triple-blinded, phase 3 clinical trial with a parallel-group design of 150 patients
Settings and conduct
All patients over 65 years referred to the trauma emergency department of Shariati Hospital with hypertrophic fractures who are candidates for surgery will be included in the study. The method of group selection is done in a triple-blind way so that neither the patient nor the physician nor the statistical analyzer has any knowledge of the patient group (case/control).
Participants/Inclusion and exclusion criteria
All patients over 65 years referred to the trauma emergency department of Shariati Hospital with pertrochanteric fractures who are candidates for surgery and have the necessary mental health to cooperate in the research, will be included in the study from April 2022 to April 2023. Patients who are not candidates for surgery due to medical problems with an ASA score of 3 or higher will be excluded from the study. Patients who have received osteoporosis treatments before surgery, including bisphosphonates, calcium and vitamin D supplements, or hormone therapy, are excluded from the study.
Intervention groups
Patients are randomly divided into case and control groups after surgery. The control group will receive daily calcium carbonate, alendronate, and vitamin D oral medication in addition to the post-up protocol while the case group will receive oral calcium hydroxyapatite, alendronate, and vitamin D oral medication daily in addition to the post-up protocol.
Main outcome variables
Pain rate; Bone density; Recurrence of fracture; Union situation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210712051854N1
Registration date:2022-03-14, 1400/12/23
Registration timing:prospective
Last update:2022-03-14, 1400/12/23
Update count:0
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Mohammad Hossein Nabian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 1444
Email address
dr.nabian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Triple blind evaluation of the efficacy of oral calcium Hydroxy-apatite on postoperative pain and bone mineral density in patients after pertrochanteric fracture surgery
Public title
Comparison of the effect of calcium carbonate and calcium hydroxyapatite supplementation on the prognosis of pertrochanteric fracture surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 65 years referred to Trauma Emergency of Shariati Hospital with pertrochanteric fracture who are candidates for surgery
Exclusion criteria:
Patients who are not candidates for surgery due to medical problems with an ASA score of 3 or higher
Patients receiving osteoporosis treatments including bisphosphonates, calcium and vitamin D supplements, or hormone therapy prior to surgery
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
150 packages of drugs containing tested drugs is prepared by the sponsoring company. Using simple randomization by computer software, one of the two types of calcium supplements is placed in each packet, and an ID is assigned to each packet. The coding table of IDs and its contents is prepared in a sealed envelope that will not be opened until the end of the study. In this way, the therapist and the patient and the data analyst will not be aware of the contents of the packages and the study will be conducted in a triple-blind manner.
Blinding (investigator's opinion)
Triple blinded
Blinding description
150 drug packs containing vitamin D supplements, alendronate, and one of the two types of calcium carbonate or calcium hydroxyapatite supplements are prepared by the project sponsoring company with the same appearance and delivered to the researchers. The allocation of one of the two types of calcium supplements will be done by random numbers table and in such a way that each type of supplement is present in 75 packages out of a total of 150 packages. Researchers will assign medication packages to patients admitted to the study, respectively. Thereby, the patient and the physician, and the data analyzer will not be informed of the drugs allocated. For confidence, there will be two additional copies of the decoded table of numbers and contents of the packages in the hand of researchers and data analyzers, which will not be opened until the end of the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-02-27, 1400/12/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1427
Health conditions studied
1
Description of health condition studied
Pertrochanteric Fracture
ICD-10 code
S72.1
ICD-10 code description
Pertrochanteric fracture
Primary outcomes
1
Description
Pain Rate Score
Timepoint
Immediately after surgery, 3 months after surgery, 6 months after surgery
Method of measurement
Visual Analog Scale Questionnaire
2
Description
Bone Mineral Density
Timepoint
Immediately after surgery, 6 months after surgery
Method of measurement
Bone-marrow densitometry
3
Description
Fracture Union
Timepoint
Every month
Method of measurement
Radiography
Secondary outcomes
1
Description
Possible side effects of the drug
Timepoint
3 months after surgery, 6 months after surgery
Method of measurement
Patient's Record and History
2
Description
Quadriceps Muscle Strength
Timepoint
After surgery, Third months follow-up, Sixth month follow-up
Method of measurement
Motor Function Measure
3
Description
Weight Bearing Time
Timepoint
3 months after surgery, 6 months after surgery
Method of measurement
Patient's Record and History
Intervention groups
1
Description
Control group: In addition to the post-protocol, daily calcium carbonate supplement for one month (totally, 30 tablets), Alendronate 70 mg once a week for three months (totally, 12 tablets), 3-Pearl Vit D 50000, one every two weeks for three months (totally, six tablets). All medicines and supplements are manufactured by Daru Salamat Pharmed Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Intervention group: In addition to the post-protocol, daily calcium hydroxyapatite supplement for one month (totally, 30 tablets), Alendronate 70 mg once a week for three months (totally, 12 tablets), 3-Pearl Vit D 50000, one every two weeks for three months (totally, six tablets). All medicines and supplements are manufactured by Daru Salamat Pharmed Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr. Mohammad Hossein Nabian
Street address
Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Daroo Salamat Pharmed
Full name of responsible person
Dr. Negar Mosavi Hasab
Street address
Unit 4, No. 27, Sharifi Brothers Alley, Above of Vanak Square, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1969813635
Phone
+98 21 8819 2740
Email
info@daroosf.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Daroo Salamat Pharmed
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
Daroo Salamat Pharmed
Full name of responsible person
Dr. Negar Mosavi Hasab
Position
Technical Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 4, No. 27, Sharifi Brothers Alley, Above of Vanak Square, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1969813635
Phone
+98 21 8819 2741
Email
Negar.moosavi@daroosf.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Nabian
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mh-nabian@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sepehr Metanat
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
s-metanat@student.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after anonymizing identifications
When the data will become available and for how long
After printing the results as an article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For further research purposes and analysis
From where data/document is obtainable
In order to receive the data, it is necessary to refer to the scientific accountant or the corresponding author of the article
What processes are involved for a request to access data/document