The effect of alendronate treatment on iPTH levels in elderlies with age-related osteoporosis: a clinical trial study
Design
72 patients with age-related osteoporosis referred to Valiasr Hospital in Zanjan will be divided into two intervention (n=36) and control (n=36) groups using block randomization.
Settings and conduct
72 patients with age-related osteoporosis referred to Valiasr Hospital, Zanjan will be divided into two intervention groups (n=36) and control groups (n=36) using block randomization. The intervention group will receive daily calcium along with alendronate 70 mg weekly. The control group will receive only daily calcium. After three months, calcium, phosphorus, VIT D, and iPTH will be checked again for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred for age-related osteoporosis.
Exclusion criteria:
1- Inability to tolerate alendronate
2- Bone diseases such as rickets
3- Bone cancers
4- Patients with rheumatoid arthritis
5- CKD patients and patients with parathyroid problems
6- Premature menopause (if menopause occurs before the age of 40, it is called premature menopause)
7- Severe secondary osteoporosis (T Score ≥ -4)
8- Osteoporosis with fractures and any possible disease that leads to secondary osteoporosis
9- Use of drugs that cause osteoporosis such as long-term use of corticosteroids.
Intervention groups
The intervention group will receive daily calcium along with alendronate 70 mg weekly. The control group will receive only daily calcium. After three months, calcium, phosphorus, VIT D, iPTH will be checked again for all patients.
Main outcome variables
intact parathyroid hormone (iPTH)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241108063637N1
Registration date:2024-12-11, 1403/09/21
Registration timing:prospective
Last update:2024-12-11, 1403/09/21
Update count:0
Registration date
2024-12-11, 1403/09/21
Registrant information
Name
Shahin Besharati Kiv
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 0804
Email address
besharati106@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of alendronate treatment on iPTH levels in elderlies with age-related osteoporosis: a clinical trial study
Public title
The effect of alendronate treatment on iPTH levels in elderlies with age-related osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women over 65 years of age and men over 70 years of age who have indications of age-related osteoporosis.
Exclusion criteria:
Severe secondary osteoporosis (T Score ≥ -4)
Osteoporosis with fractures and any possible disease that leads to secondary osteoporosis
Use of drugs that cause osteoporosis, such as long-term use of corticosteroids
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be used for randomization. The website https://www.sealedenvelope.com will be used online to generate the block random sequence, creating blocks of size 6. Ultimately, 12 blocks of 6 will be created, with 36 patients in each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
First Floor,Building No. 1, Zanjan University of Medical Sciences and Health Services, beginning of Jomhuri Eslami Street, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2024-04-16, 1403/01/28
Ethics committee reference number
IR.ZUMS.REC.1403.029
Health conditions studied
1
Description of health condition studied
osteoporosis
ICD-10 code
M82.8
ICD-10 code description
Osteoporosis in other diseases classified elsewhere
Primary outcomes
1
Description
intact parathyroid hormone (iPTH)
Timepoint
Before the start of the intervention and 3 months after the intervention
Method of measurement
To measure iPTH, a blood sample is taken from the patient. You must also observe fasting conditions for 8 to 12 hours.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Only calcium will be given daily along with alendronate 70 mg weekly. After three months, calcium, phosphorus, VIT D, and iPTH will be checked again for all patients.