Home » Trials » SLCTR/2008/018
Effect of alendronate or calcium plus vitamin D3 on thalassemic osteopathy; a randomized placebo controlled double blind clinical trial
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SLCTR Registration Number
SLCTR/2008/018
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Effect of alendronate or calcium plus vitamin D3 on thalassemic osteopathy; a randomized placebo controlled double blind clinical trial
Public Title of Trial
Effect of alendronate or calcium plus vitamin D3 on thalassemic osteopathy
Disease or Health Condition(s) Studied
Thalassemic osteopathy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Whether alendronate vs vitamin D3 plus calcium be effective in patients with thalassemic osteopathy to improve bone mineralization ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
One group will receive alendronate daily for one year while other group will receive vitamin D3 plus calcium daily for one year. Administration of alendronate Patients will receive 5 mg/day for a body weight of = 20 kg; 10 mg/day for > 20 kg oral alendronate for one year of period (Bianchi ML 2000). Adverse effects of alendronate include oesophageal reactions, abdominal pain and distention, diarrhea and constipation, rarely rash, erythema and photosensitivity (Bianchi Mlet al 2000). To prevent oesophageal reactions following precautions will be taken;Swallow the tablet whole with a full glass of water on an empty stomach at least 30 minutes before breakfast, stand or sit upright for at least 30 minutes and do not lie down until after eating breakfast. Patient will be asked not to take the tablets at bed time or before rising (Bianchi Mlet al 2000). Administration of calcitriol and calcium Patients will receive 1 g of calcium and 400 IU of vitamin D3 daily for one year of period (Warady BD 1994)Adverse effects of calcium include hypercalcaemia due to overdosage. Symptoms of overdosage of vitamin D3 Include anorexia, nausea and vomiting, diarrhea weight loss, polyuria and sweating (Bianchi Mlet al 2000). Response to treatment will be monitored by DXA in 3 months intervals
Inclusion criteria
Patients who are diagnosed having thalassemic osteopathy who would admit to Teaching Hospital Karapitiya for regular blood transfusion will be selected for this study
Exclusion criteria
Primary outcome(s)
|
1.
Bone mineral density changes after administering alendronate, calcium and calcitriol |
[ Every 3 months upto one year after commencement of treatment ] |
Secondary outcome(s)
|
1.
Reduction of bone pain and fracture risk |
[ At the end of one year after commencing the treatment ] |
Target number/sample size
20
Countries of recruitment
Sri Lanka
Anticipated start date
2008-10-01
Anticipated end date
2010-01-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
University grant allocated for academic research in the Faculty of Medicine, University of Ruhuna
Regulatory approvals
Status
Approved
Date of Approval
2008-07-28
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr Sudheera Jayasinghe
Probationary Lecturer
Department of Pharmacology, Faculty of Medicine, University of Ruhuna
0772988312
091-2222314
sudheerasj@yahoo.com
Contact Person for Public Queries
Dr Sudheera Jayasinghe
Probationary Lecturer
Department of Pharmacology, Faculty of Medicine, University of Ruhuna
0772988312
091-2222314
sudheerasj@yahoo.com
Primary study sponsor/organization
Faculty of Medicine, University of Ruhuna
P O Box 70, Karapitiya, Galle
0912234801
091-2222314
deanmedruh@sltnet.lk
www.ruh.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
