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Abstract
Objectives: To study the efficacy and safety of once-monthly oral ibandronate in the prevention of glucocorticoid (GC)-induced osteoporosis (GIOP) in postmenopausal women with inflammatory rheumatic diseases.
Method: A randomized, double-blind, placebo-controlled, parallel-group study of 140 postmenopausal women was conducted. At baseline, the mean lumbar spine (LS) (L1–L4) bone mineral density (BMD) was normal or osteopaenic (T-score ≥ –2.0) and the patients were receiving treatment with 5–15 mg/day of prednisone equivalent. Patients were randomized 1:1 to receive either monthly oral ibandronate 150 mg or placebo for 12 months. All patients received vitamin D and calcium supplements. The primary endpoint was the relative change in mean LS BMD from baseline to 12 months.
Results: Mean LS BMD increased significantly by 2.6% and 3.2% from baseline to 6 and 12 months with ibandronate compared to 0.3% and –0.1% with placebo, respectively (p < 0.001). Comparable significant mean increases were also found in trochanter, femoral neck and total hip BMDs at 12 months. Reductions in the serum levels of bone turnover markers C-terminal telopeptide of type I collagen (sCTX), N-terminal propeptide of type I procollagen (P1NP), and tartrate-resistant acid phosphatase (TRACP) were significantly more marked in the ibandronate group than in the placebo group at 1, 6, and 12 months. Adverse events (AEs) were reported at a similar frequency in both groups. A higher proportion of serious AEs (SAEs) were reported in the ibandronate group without emergence of any single SAE.
Conclusions: Once-monthly oral ibandronate provides a significant increase in LS and total hip BMD with an acceptable safety profile in postmenopausal women treated with low-dose GCs for inflammatory rheumatic diseases.
Acknowledgements
Other members of the ONCE trial group: Esko Alhava, Department of Orthopaedics and Traumatology, Kuopio University Hospital, Kuopio; Khajag Azezian, Tikkurila Health Centre, Vantaa; Kari Eklund, Wihuri Research Institute, Helsinki; Mikko Hakola, Department of Medicine, Jyväskylä Central Hospital, Jyväskylä; Risto Hämeenkorpi, Deaconess Institute of Oulu, Oulu; Harri Hämäläinen, Helsinki University Central Hospital, Helsinki; Pia Isomäki, Department of Internal Medicine, Tampere University Hospital, Tampere; Pentti Järvinen, Kiljava Medical Research, Hyvinkää; Matti Jääskivi, Tikkurila Health Centre, Vantaa; Krista Karstila, Department of Internal Medicine, Tampere University Hospital, Tampere; Markku Kauppi, Päijät-Häme Central Hospital, Lahti; Arvo Koistinen, Department of Medicine, Jyväskylä Central Hospital, Jyväskylä; Aulikki Kononoff, Department of Internal Medicine, Kuopio University Hospital, Kuopio; Sirkka Koskinen, Kiljava Medical Research, Hyvinkää; Timo Möttönen, Department of Medicine, Turku University Central Hospital, Turku; Klaus Suni, Kyllö Health Centre, Jyväskylä; and Tea Uusitalo, Kanta-Häme Central Hospital, Hämeenlinna, Finland.
This study was funded by Roche Finland and GSK Pharma Europe.