1.
Higher response with bone mineral density increase with monthly injectable ibandronate 1 mg compared with oral risedronate in the MOVER study.
Nakano, T, Yamamoto, M, Hashimoto, J, Tobinai, M, Yoshida, S, Nakamura, T
Journal of bone and mineral metabolism. 2016;(6):678-684
Abstract
We examined response to bone mineral density (BMD) gains in the MOVER study following treatment with intravenous (IV) ibandronate 1 mg/month, and investigated the characteristics of a non-responder group. At 1 year, responder rates for patients with BMD increases >0 % were similar with IV ibandronate 0.5 or 1 mg/month and oral risedronate 2.5 mg/day. However, after 3 years, responder rates with BMD increases ≥3 % were highest with ibandronate 1 mg at all bone sites (>80 % at the lumbar spine [L2-L4] and >50 % at all femur sites, which was significantly higher than with risedronate). Non-responders were defined by BMD increases ≤3 % at L2-L4 or ≤0 % at total hip, and ≤50 % reduction in creatinine-corrected urinary collagen type 1 cross-linked C-telopeptide (uCTX) from baseline to 1 year. There were a small number of non-responders in the ibandronate 1 mg group: 3.3 % (10/299) with ≤0 % total hip BMD increase and ≤50 % uCTX reduction from baseline. These non-responders had lower 25-hydroxyvitamin D (25[OH]D) levels than responders, but no differences in kidney function, L2-L4 BMD or bone turnover marker baseline values. Throughout the study, non-responders failed to show any increases in BMD. Our analysis demonstrates significantly higher responder rates with IV ibandronate 1 mg/month than with risedronate at 3 years. A small number of non-responders in the ibandronate group had lower 25(OH)D baseline levels than responders, suggesting that 25(OH)D levels could be a useful indicator of BMD response to therapy.
2.
[Bone and calcium update; diagnosis and therapy of metabolic bone disease update. Advances in clinical trials for osteoporosis in Japan].
Nakamura, T
Clinical calcium. 2011;(12):145-51
Abstract
Microdensitometry of the metacarpal bone on radiograph was first set up as the endpoint of the treatment in clinical trials in Japan in 1980s. Then, radial bone mineral content obtained by single photon absorptiometry was used. In 1990s, lumbar spine BMD measured by DXA became the major endpoint of the study which was designed as prospective, randomized, double-blind, controlled trial. In 2000s, assessments on the incidences of the vertebral fractures have become mandatory as the primary endpoint of the placebo-controlled trial. The numbers of the subjects required in the study are getting larger and the subtleties in the study including adverse events more important along the progress of evidence-based medicine.
3.
[Role of pharmaceutical intervention in the treatment of osteoporosis and prevention of fracture].
Nakamura, T
Nihon rinsho. Japanese journal of clinical medicine. 2009;(5):903-8
Abstract
Evidences of reduction in fracture risk have been accumulated increasingly in patients with osteoporosis. More than ten pharmaceutical agents have been shown to be effective to vertebral fracture risk, and six agents are also effective to reduce hip fracture risk as well. Recent analyses are revealing that the uses of agents to prevent fracture are cost-effective, if the agents potently reduce both vertebral and hip fractures. Pharmaceutical intervention, when combined with appropriate nutritional support and low intensity exercise, is currently eligible to be the primary strategy in subjects with increased risk of fracture in the health care of aged persons to maintain their daily activity and quality of life.
4.
[Muscle and bone health as a risk factor of fall among the elderly. Prevention of fracture and bisphosphonate].
Nakamura, T
Clinical calcium. 2008;(6):821-7
Abstract
Fracture risk reduction in patients with osteoporosis by nitrogen containing bisphosphonate (N-BP) has been well confirmed in the daily practices. N-BPs suppress bone resorption by inhibiting farnesyl diphosphate synthase in mevalonate pathway, reducing protein-prenylation, consequently disrupting the membrance structure in osteoclasts. A once-yearly infusion of zoledronic acid during 3-year period significantly reduced the risk of vertebral fracture by 70% and that of hip fracture by 41% in patients with postmenopausal osteoporosis at the mean age of 73. The annual infusion within 90 days after surgery was associated with a reduction the rate of new fractures and with improved survival. We may count N-BP as one of essential drugs in the health care for elderlies.