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Effect of alendronate or calcium plus vitamin D3 on thalassemic osteopathy

Effect of alendronate or calcium plus vitamin D3 on thalassemic osteopathy; a randomized placebo controlled double blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2008/018
Enrollment
20
Registered
2008-09-19
Start date
2008-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassemic osteopathy

Interventions

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
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,
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 breakf

Sponsors

Faculty of Medicine, University of Ruhuna
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Bone mineral density changes after administering alendronate, calcium and calcitriol [Every 3 months upto one year after commencement of treatment ]

Secondary

MeasureTime frame
Reduction of bone pain and fracture risk [At the end of one year after commencing the treatment ]

Countries

Sri Lanka

Contacts

Public ContactDr Sudheera Jayasinghe

Probationary Lecturer

sudheerasj@yahoo.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026