BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate the effect of zoledronic acid (ZA) on thalassemia-induced osteoporosis. DESIGN AND METHODS: We studied 66 thalassemia patients with osteoporosis, who were randomized to receive 4 mg ZA iv, every 6 months (23 patients; group A) or every 3 months (21 patients; group B), or to receive placebo every 3 months (22 patients; group C), for a period of 1 year. Bone mineral density (BMD) of the lumbar spine, femoral neck and wrist was determined before and 12 months after treatment. Pain scores and markers of bone resorption [C-telopeptide of collagen type-I (CTX), 5b-isoform of TRAP], bone formation [bone-alkaline phosphatase (bALP), osteocalcin (OC), C-telopeptide of procollagen type-I (CICP)], and osteoclast stimulators [sRANKL, osteoprotegerin (OPG), osteopontin] were also measured at baseline and before each treatment administration. RESULTS: The values of CTX, bALP, CICP, sRANKL, and OPG were higher in the all patients than in the controls. Patients in group A showed no differences in BMD of all sites at 12 months, while they had reductions in bone pain, bALP, OC and OPG. Conversely patients in group B had a significant increase in their lumbar spine BMD, which was accompanied by dramatic reductions in bone pain, CTX, bALP, CICP, and OC. Patients in group C showed no alteration in BMD of any studied site or in bone pain, while they had an aggravation in bone resorption. INTERPRETATION AND CONCLUSIONS:ZA, at a dose of 4 mg, iv, every 3 months is an effective treatment for increasing BMD and reducing bone resorption in thalassemia-induced osteoporosis.
RCT Entities:
BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate the effect of zoledronic acid (ZA) on thalassemia-induced osteoporosis. DESIGN AND METHODS: We studied 66 thalassemiapatients with osteoporosis, who were randomized to receive 4 mg ZA iv, every 6 months (23 patients; group A) or every 3 months (21 patients; group B), or to receive placebo every 3 months (22 patients; group C), for a period of 1 year. Bone mineral density (BMD) of the lumbar spine, femoral neck and wrist was determined before and 12 months after treatment. Pain scores and markers of bone resorption [C-telopeptide of collagen type-I (CTX), 5b-isoform of TRAP], bone formation [bone-alkaline phosphatase (bALP), osteocalcin (OC), C-telopeptide of procollagen type-I (CICP)], and osteoclast stimulators [sRANKL, osteoprotegerin (OPG), osteopontin] were also measured at baseline and before each treatment administration. RESULTS: The values of CTX, bALP, CICP, sRANKL, and OPG were higher in the all patients than in the controls. Patients in group A showed no differences in BMD of all sites at 12 months, while they had reductions in bone pain, bALP, OC and OPG. Conversely patients in group B had a significant increase in their lumbar spine BMD, which was accompanied by dramatic reductions in bone pain, CTX, bALP, CICP, and OC. Patients in group C showed no alteration in BMD of any studied site or in bone pain, while they had an aggravation in bone resorption. INTERPRETATION AND CONCLUSIONS:ZA, at a dose of 4 mg, iv, every 3 months is an effective treatment for increasing BMD and reducing bone resorption in thalassemia-induced osteoporosis.
Authors: A D Dede; G Trovas; E Chronopoulos; I K Triantafyllopoulos; I Dontas; N Papaioannou; S Tournis Journal: Osteoporos Int Date: 2016-08-08 Impact factor: 4.507
Authors: A Gaudio; N Morabito; A Xourafa; I Macrì; A Meo; S Morgante; A Trifiletti; A Lasco; N Frisina Journal: J Endocrinol Invest Date: 2008-02 Impact factor: 4.256