title: Intravenous zoledronic acid treatment in thalassemia-induced osteoporosis: results of a phase II clinical trial.
abstract: Osteoporosis is an important cause of morbidity in beta-thalassemia patients. Bisphosphonates have been recently used for the treatment of osteoporosis in beta-thalassemia. This study is a prospective quasi-experimental study to assess the efficacy and safety of zoledronic acid in thalassemics with osteoporosis. Eighteen thalassemia patients with osteoporosis were given zoledronic acid 4 mg intravenously every 3 months over a period of 12 months. The efficacy of treatment was assessed by measuring (BMD) at the lumbar spine, femoral neck, and hip at baseline, 6, and 12 months. Z-score was used to measure the BMD. Other medical assessments included markers of bone formation and resorption (bone alkaline phosphatase (BAP), osteocalcin (OC), and urinary deoxypyridinoline), and the assessment of pain score, analgesic score, and performance score. Ten thalassemic osteoporotic patients were followed up only with serial BMDs as controls. Both groups had no significant difference with respect to age, gender, and baseline BMD. Patients taking zoledronic acid had a significant increase in their lumbar spine, femoral neck, trochanter, and total hip BMD measurements over the 12-month period. Patients in the control group did not have any significant change in BMD measurements. There was a significant change in the levels of OC and BAP over the 12-month follow-up period. There was also a significant decrease in the number of painful sites experienced by the patients. Treatment of thalassemic osteoporotic patients with zoledronic acid is very effective in increasing BMD at the lumbar spine and hip and in reducing pain; it is also well-tolerated.
authors.affiliation: Department of Internal Medicine, American University of Beirut-Medical Center, P.O. Box 113-0236, Riad El-Solh St., 1107-2020 Beirut, Lebanon.
authors.forename: Zaher K
authors.initials: ZK
authors.lastname: Otrock
authors.forename: Sami T
authors.initials: ST
authors.lastname: Azar
authors.forename: Wael A
authors.initials: WA
authors.lastname: Shamseddeen
authors.forename: Dany
authors.initials: D
authors.lastname: Habr
authors.forename: Adlette
authors.initials: A
authors.lastname: Inati
authors.forename: Suzane
authors.initials: S
authors.lastname: Koussa
authors.forename: Rami A R
authors.initials: RA
authors.lastname: Mahfouz
authors.forename: Ali T
authors.initials: AT
authors.lastname: Taher
mesh_terms: D000293:Adolescent; D000328:Adult; D000469:Alkaline Phosphatase / Q000378:metabolism; D015415:Biomarkers / Q000378:metabolism; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D007275:Injections, Intravenous; D008297:Male; D010012:Osteogenesis / Q000187:drug effects*; D010024:Osteoporosis / Q000188:drug therapy* / Q000201:enzymology / Q000209:etiology; D011446:Prospective Studies; D013789:Thalassemia / Q000150:complications* / Q000188:drug therapy / Q000201:enzymology; D000077211:Zoledronic Acid
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid; D000469:Alkaline Phosphatase