Safety and efficacy of bisphosphonates in thalassemia patients with osteopenia/osteoporosis

Background: Osteoporosis in Thalassemia Major (TM) represents a prominent cause of morbidity. Calcium is important for bone health throughout the life. If not well transfused, the medullary as well as extramedullary erythropoiesis is stimulated. This leads to thinning of the cortices of long bones and marked dilatation of the medullary cavities. Aims and Objectives: To evaluate the efficacy of bisphosphonates in thalassemia patients with osteopenia/ osteoporosis and to study the safety profile of bisphosphonates. Material and Methods: The prospective interventional study was conducted from January 2019-March 2020 at thalassemia day care centre of a tertiary care hospital after approval from Institutional Ethics Committee. Of the 150 thalassemia patients, 40 diagnosed with B-thalassemia major with more than 7 years of age, who were on regular transfusion and with Dual X-Ray Absorptiometry (DEXA) scan showing osteopenic/osteoporotic changes were exclusively included in the study. Age appropriate consent, history, clinical examination and biochemical investigations were done. All patients whose Bone Mineral Density (BMD) was showing osteoporosis were started on Alendronate 25 mg/week orally in the morning on empty stomach. The patients were followed up monthly for one year, after which they were evaluated with repeat biochemical tests and DEXA scan. Results: Majority of children were in the age group of 10-15 years (50%) with male predominance (55%). At pre-treatment, 24 (60%) and 20 (50%) patients had backache and bone pain respectively which significantly reduced to 4 (10%) each at post-treatment. Mean serum calcium improved from 8.27 g% before treatment to 9.26 g% post-treatment. Of the 40 patients, 8 (20%) had osteopenia and 32 (80%) had osteoporosis before starting the therapy. Post-treatment, there was significant increase in bone mass, 10 (25%) patients had normal Z score, 14 (35%) patients had osteopenia and only 16 (40%) had osteoporosis with improved BMD. Only 2 (5%) children had developed twitching secondary to hypocalcemia. Conclusion: DEXA scan must be done routinely in all thalassemia patients. Bisphosphonates along with adequate calcium can effectively reduce bone related morbidity in thalassemics with good safety profile.