Effect of alendronate or calcium plus vitamin D3 on thalassemic osteopathy

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2008/018
• Date of registration: 19/09/2008
• Primary sponsor: Faculty of Medicine, University of Ruhuna
• Public title: Effect of alendronate or calcium plus vitamin D3 on thalassemic osteopathy
• Scientific title: Effect of alendronate or calcium plus vitamin D3 on thalassemic osteopathy; a randomized placebo controlled double blind clinical trial
• Date of first enrolment: 1/10/2008
• Target sample size: 20
• Recruitment status: Completed
• URL: http://www.slctr.lk/trial_details.asp?reg_id={3647741C-BC0E-4463-8D87-DAE283F9CDEA}
• Study type: Interventional
• Study design: A randomized placebo controlled double blind clinical trial

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr Sudheera Jayasinghe
• Affiliation: Probationary Lecturer

• Name: Dr Sudheera Jayasinghe
• Affiliation: Probationary Lecturer

Key inclusion & exclusion criteria

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: 1. Patient/ parents or guardian who does not give the consent.
2. Inability to comply with the visit schedule.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Thalassemic osteopathy

Intervention(s)

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

Primary Outcome(s)

Bone mineral density changes after administering alendronate, calcium and calcitriol

Secondary Outcome(s)

Reduction of bone pain and fracture risk

Secondary ID(s)

None

Source(s) of Monetary Support

University grant allocated for academic research in the faculty of Medicine, University of Ruhuna