Effect of monthly intravenous ibandronate injections on vertebral or non-vertebral fracture risk in Japanese patients with high-risk osteoporosis in the MOVER study

We examined the efficacy of intravenous (IV) ibandronate 1 mg/month in patient subgroups in the phase III MOVER study. Here we present results of analyses on the incidence of fractures in patients with prevalent vertebral fractures (1 or ≥2, and ≥3) at screening and femoral neck (FN) bone mineral de...

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Veröffentlicht in:Journal of bone and mineral metabolism 2017, Vol.35 (1), p.58-64
Hauptverfasser: Ito, Masako, Tobinai, Masato, Yoshida, Seitaro, Hashimoto, Junko, Nakamura, Toshitaka
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container_issue 1
container_start_page 58
container_title Journal of bone and mineral metabolism
container_volume 35
creator Ito, Masako
Tobinai, Masato
Yoshida, Seitaro
Hashimoto, Junko
Nakamura, Toshitaka
description We examined the efficacy of intravenous (IV) ibandronate 1 mg/month in patient subgroups in the phase III MOVER study. Here we present results of analyses on the incidence of fractures in patients with prevalent vertebral fractures (1 or ≥2, and ≥3) at screening and femoral neck (FN) bone mineral density (BMD) T scores ≥−2.5 or 
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Here we present results of analyses on the incidence of fractures in patients with prevalent vertebral fractures (1 or ≥2, and ≥3) at screening and femoral neck (FN) bone mineral density (BMD) T scores ≥−2.5 or &lt;−2.5, and &lt;−3.0 at baseline. The per-protocol set comprised 1134 patients (ibandronate 0.5 mg/month n  = 376; ibandronate 1 mg/month n  = 382; risedronate oral 2.5 mg/day n  = 376). The incidence of vertebral fractures in patients with 1 or ≥2 prevalent vertebral fractures was 11.2 and 20.4 %, respectively, with ibandronate 1 mg/month, and 12.6 and 22.1 %, respectively, with risedronate. In patients with FN BMD T scores ≥−2.5 or &lt;−2.5, the vertebral fracture incidence was 13.7 and 16.4 %, respectively, with ibandronate 1 mg/month, and 17.3 and 19.1 %, respectively, with risedronate. The incidence of non-vertebral fractures in patients with ≥2 prevalent vertebral fractures or FN BMD T score &lt;−2.5 was 7.6 and 7.6 %, respectively, with ibandronate 1 mg/month, and 9.5 and 9.4 %, respectively, with risedronate. Fracture incidence was consistently lower, but not significant, with ibandronate 1 mg/month than with risedronate in patients with ≥2 prevalent vertebral fractures and FN BMD T score &lt;−2.5. 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Here we present results of analyses on the incidence of fractures in patients with prevalent vertebral fractures (1 or ≥2, and ≥3) at screening and femoral neck (FN) bone mineral density (BMD) T scores ≥−2.5 or &lt;−2.5, and &lt;−3.0 at baseline. The per-protocol set comprised 1134 patients (ibandronate 0.5 mg/month n  = 376; ibandronate 1 mg/month n  = 382; risedronate oral 2.5 mg/day n  = 376). The incidence of vertebral fractures in patients with 1 or ≥2 prevalent vertebral fractures was 11.2 and 20.4 %, respectively, with ibandronate 1 mg/month, and 12.6 and 22.1 %, respectively, with risedronate. In patients with FN BMD T scores ≥−2.5 or &lt;−2.5, the vertebral fracture incidence was 13.7 and 16.4 %, respectively, with ibandronate 1 mg/month, and 17.3 and 19.1 %, respectively, with risedronate. The incidence of non-vertebral fractures in patients with ≥2 prevalent vertebral fractures or FN BMD T score &lt;−2.5 was 7.6 and 7.6 %, respectively, with ibandronate 1 mg/month, and 9.5 and 9.4 %, respectively, with risedronate. Fracture incidence was consistently lower, but not significant, with ibandronate 1 mg/month than with risedronate in patients with ≥2 prevalent vertebral fractures and FN BMD T score &lt;−2.5. 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Here we present results of analyses on the incidence of fractures in patients with prevalent vertebral fractures (1 or ≥2, and ≥3) at screening and femoral neck (FN) bone mineral density (BMD) T scores ≥−2.5 or &lt;−2.5, and &lt;−3.0 at baseline. The per-protocol set comprised 1134 patients (ibandronate 0.5 mg/month n  = 376; ibandronate 1 mg/month n  = 382; risedronate oral 2.5 mg/day n  = 376). The incidence of vertebral fractures in patients with 1 or ≥2 prevalent vertebral fractures was 11.2 and 20.4 %, respectively, with ibandronate 1 mg/month, and 12.6 and 22.1 %, respectively, with risedronate. In patients with FN BMD T scores ≥−2.5 or &lt;−2.5, the vertebral fracture incidence was 13.7 and 16.4 %, respectively, with ibandronate 1 mg/month, and 17.3 and 19.1 %, respectively, with risedronate. The incidence of non-vertebral fractures in patients with ≥2 prevalent vertebral fractures or FN BMD T score &lt;−2.5 was 7.6 and 7.6 %, respectively, with ibandronate 1 mg/month, and 9.5 and 9.4 %, respectively, with risedronate. Fracture incidence was consistently lower, but not significant, with ibandronate 1 mg/month than with risedronate in patients with ≥2 prevalent vertebral fractures and FN BMD T score &lt;−2.5. The efficacy of the fracture reduction of monthly IV ibandronate appears consistent and seemingly independent of the number of prevalent vertebral fractures or baseline BMD values.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>26614597</pmid><doi>10.1007/s00774-015-0723-x</doi><tpages>7</tpages></addata></record>
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subjects Aged
Aged, 80 and over
Asian Continental Ancestry Group
Bone Density - drug effects
Diphosphonates - administration & dosage
Female
Femoral Neck Fractures - epidemiology
Femoral Neck Fractures - etiology
Femoral Neck Fractures - metabolism
Femoral Neck Fractures - prevention & control
Femur Neck - metabolism
Humans
Japan - epidemiology
Male
Medicine
Medicine & Public Health
Metabolic Diseases
Middle Aged
Original Article
Orthopedics
Osteoporosis - complications
Osteoporosis - drug therapy
Osteoporosis - epidemiology
Osteoporosis - metabolism
Risedronate Sodium - administration & dosage
Spinal Fractures - epidemiology
Spinal Fractures - etiology
Spinal Fractures - metabolism
Spinal Fractures - prevention & control
Spine - metabolism
title Effect of monthly intravenous ibandronate injections on vertebral or non-vertebral fracture risk in Japanese patients with high-risk osteoporosis in the MOVER study
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