Assessment of the effect of Denosumab in the improvement of bone mineral densitometry (BMD) in osteoporotic postmenopausal women
Design
Clinical trial without a control group, non-blind, non-randomized, in phase 3 on 202 patients.
Settings and conduct
This clinical trial will be performed to determine the effectiveness of the denosumab drug on the bone density in osteoporosis patients. patients referred to Imam Reza Hospital (501 Army) in Tehran, after bone density testing, if confirmed by osteoporosis by a physician and conscious consent, intervened and received a 60 mg dose of denosumab subcutaneously at baseline and 6 months later. People will return after 6 month and have a bone density test again.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Postmenopausal women (aged 45 to 75 years old) diagnosed with osteoporosis by densitometry via Dexa(dual-energy Xray absorptiometry).
Exclusion criteria include:Lack of consent for being in the trial Having hypersensitivity to denosumab or any component in the formulation Malabsorption syndrome History of thyroid surgery, parathyroid surgery or intestinal resection which has been caused, malabsorption Patient
Intervention groups
After performing a bone density test and assuring osteoporosis, the person will receive a 60 mg dose of denosumab subcutaneously at baseline and 6 months later. 6 month after the injection, the person will have a bone resuscitation test and the effectiveness of the denosumab will be checked.
Main outcome variables
T score, Percentage change in Bone mineral density (BMD)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210803052067N1
Registration date:2021-09-21, 1400/06/30
Registration timing:retrospective
Last update:2021-09-21, 1400/06/30
Update count:0
Registration date
2021-09-21, 1400/06/30
Registrant information
Name
Atie Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2205 2496
Email address
dr.kazemiatie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-20, 1399/04/30
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of bone density changes before and after administration of at least one year of danozoomab in patients referred to Imam Reza Hospital
Public title
Bone density changes before and after administration of danozoomab
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women (aged 45 to 75 years old) diagnosed with osteoporosis by densitometry via Dexa(dual energy Xray absorptiometry).
Exclusion criteria:
Lack of consent for being in the trial
Having hypersensitivity to denosumab or any component in the formulation
Malabsorption syndrome
History of thyroid surgery, parathyroid surgery or intestinal resection which has been caused malabsorption Patient
Age
From 45 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
202
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 Tehran University of Medical Science
Street address
First floor, NO 21,Dameshgh st, Felestin st.Keshavar Blv
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.AJAUMS.REC.1399.058
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M80
ICD-10 code description
Osteoporosis with current pathological fracture
Primary outcomes
1
Description
Percentage change in Bone mineral density(BMD) at the lumbar spine (L1-L4), femoral neck, and total hip
Timepoint
Baseline and at 12th month of the study
Method of measurement
BMD by dual-energy x-ray absorptiometry Hologic 4500 or higher
Secondary outcomes
1
Description
(T score)
Timepoint
At the beginning of the study and12 months later
Method of measurement
Bone densitometry
Intervention groups
1
Description
Intervention group: After performing a bone density test and assuring osteoporosis, the person will receive a 60 mg dose of denosumab(Xgeva®, produced by Amgen ) subcutaneously at baseline and 6 months later. 6 months after the injection, the person will have a bone resuscitation test and the effectiveness of the denosumab will be checked.