0
selected
-
1.
Renal Phosphate Reabsorption is Correlated with the Increase in Lumbar Bone Mineral Density in Patients Receiving Once-Weekly Teriparatide.
Takeuchi, Y, Kuroda, T, Sugimoto, T, Shiraki, M, Nakamura, T
Calcified tissue international. 2016;(2):186-92
-
-
Free full text
-
Abstract
In order to assess the changes in serum calcium and phosphate and the changes in renal tubular phosphate reabsorption (TmP/GFR) and to evaluate the association between these indices and the increase in bone mineral density (BMD) with once-weekly intermittent administration of teriparatide (TPTD), the results from the teriparatide once-weekly efficacy research (TOWER) trial were re-analyzed. The TOWER trial studied postmenopausal women and older men with osteoporosis. Patients were randomly assigned to receive TPTD 56.5 μg or placebo for 72 weeks. Of these patients, the present study investigated those whose calcium and phosphate levels and lumbar BMD (L-BMD) were measured (TPTD group, n = 153 and Placebo group, n = 137). The TPTD group had significantly lower serum phosphate, calcium-phosphate product, and TmP/GFR at weeks 4, 24, 48, and 72 and urinary fractional calcium excretion (FECa) at weeks 12, 48, and 72 (p < 0.05). In the TPTD group, the serum phosphate and TmP/GFR during early treatment (4, and 12 weeks) showed a significant positive correlation with the percent change in L-BMD at weeks 48 and 72. Based on multivariate analysis corrected for age, BMI, and L-BMD at the start of treatment, serum phosphate and TmP/GFR at week 4 showed a significant correlation with the percent change in L-BMD. This study suggests that the L-BMD response to once-weekly long-term TPTD treatment is associated with circulating phosphate or with the status of its renal reabsorption. Preventing decrease in serum phosphate levels may be important in acquiring greater L-BMD with once-weekly TPTD.
-
2.
Efficacy of combined treatment with alendronate (ALN) and eldecalcitol, a new active vitamin D analog, compared to that of concomitant ALN, vitamin D plus calcium treatment in Japanese patients with primary osteoporosis.
Sakai, A, Ito, M, Tomomitsu, T, Tsurukami, H, Ikeda, S, Fukuda, F, Mizunuma, H, Inoue, T, Saito, H, Nakamura, T, et al
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2015;(3):1193-202
-
-
Free full text
-
Abstract
UNLABELLED Combined treatment with alendronate and eldecalcitol was found to be more effective in reducing the bone turnover markers and increasing bone mineral density than alendronate treatment with vitamin D3 and calcium supplementation in the osteoporotic patients. INTRODUCTION We compared the clinical efficacy and safety of combined treatment with alendronate plus eldecalcitol (ALN + ELD) with those of treatment with ALN plus vitamin D and calcium (ALN + VitD). METHODS Osteoporotic 219 patients were randomly assigned to the ALN + ELD, or the ALN + VitD group. Primary endpoint was the inter-group differences in lumbar spine BMD (L-BMD) at patient's last visit. Secondary endpoints included the differences in BMD at other sites and the bone turnover marker (BTM) levels. RESULTS L-BMD, total hip BMD and femoral neck (FN-BMD) increased from baseline by 7.30, 2.41, and 2.70 % in the ALN + ELD group, and by 6.52, 2.27, and 1.18% in the ALN + VitD group, respectively. Inter-group differences of the L-BMD and total hip BMD values were not significant. The increase of the FN-BMD was larger in the ALN + ELD group than the ALN + VitD group. Reductions of the BTMs were greater in the ALN + ELD group than the ALN + VitD group. Interaction of the percent increase of the L-BMD with the baseline values of the BTMs was observed in the ALN + VitD group only. The increases of the FN-BMD in patients with lower baseline values of type-I-collagen C-telopeptide (sCTX) and serum 25(OH) D levels <20 ng/mL were significantly larger in the ALN + ELD group than the other group. CONCLUSION Combination treatment of ALN plus ELD was more effective in reducing the BTMs and increasing the FN-BMD than ALN treatment with vitamin D3 and calcium.
-
3.
Design of a randomized clinical trial of concurrent treatment with vitamin K2 and risedronate compared to risedronate alone in osteoporotic patients: Japanese Osteoporosis Intervention Trial-03 (JOINT-03).
Tanaka, S, Miyazaki, T, Uemura, Y, Kuroda, T, Miyakawa, N, Nakamura, T, Fukunaga, M, Ohashi, Y, Ohta, H, Mori, S, et al
Journal of bone and mineral metabolism. 2014;(3):298-304
Abstract
Concurrent treatments with bisphosphonates and vitamin K are promising given that bisphosphonates possibly interfere with vitamin K activation. This is a prospective, multi-center, open-labeled, randomized trial of the efficacy of concurrent treatment with vitamin K2 and risedronate compared with risedronate alone and to explore subsets of patients for which concurrent treatment is particularly efficacious (trial identification number UMIN000000991). Inclusion criteria are women who meet the criteria for pharmacological therapy for osteoporosis, aged ≥65 years, have any of pre-specified risk factors, can walk unassisted, and are able to answer questionnaires. Exclusion criteria are prior warfarin use, secondary osteoporosis or non-osteoporotic metabolic bone diseases, contraindication for vitamin K2 and risedronate, hyper- or hypoparathyroidism, mental disorders, prevalent vertebral fracture at ≥6 sites, severe degenerative spinal deformation between T4 and L4, serious heart, liver, or kidney disease, or bisphosphonate use within the previous 6 months. Patients were recruited from 123 institutes between January 2008 and February 2010, and allocated to vitamin K2 (45 mg/day) and risedronate (2.5 mg/day or 17.5 mg/week) or risedronate alone (2.5 mg/day or 17.5 mg/week) groups. Primary endpoint is a vertebral or non-vertebral fracture. Secondary endpoints are bone mineral density, height, undercarboxylated osteocalcin, JOQOL, EQ-5D and safety. A sample size of 910 subjects per group and 2-year follow-up will provide 80 % power to detect 35 % risk reduction for fracture, with a two-sided significance level of 5 %. Subgroup analysis stratified to adjustment factors for random allocation, body mass index, 25-hydroxyvitamin D, estimated glomerular filtration rate, grade of vertebral fracture, JOQOL, EQ-5D, and co-morbidity is pre-specified.
-
4.
[Effect and role of teriparatide in the treatment of osteoporosis].
Nakamura, T
Clinical calcium. 2012;(3):309-14
Abstract
Teriparatide, a treatment formula of parathyroid hormone (PTH) , is a powerful anabolic agent on bone, improving its mass, geometry and microarchitecture. It can decrease the occurrence of fracture in the subjects with increased fracture risks. Teriparatide can provide good protection against fracture using as monotherapy, and possibly as combination with an antiresorptive agent such as zoledronate. Teriparatide should be considered in patients with osteoporosis who sustained the reduction of BMD or fracture on established bisphosphonates or SERMs. Treatment period of teriparatide is 1.5-2 years and consecutive use of antiresorptive agents is greatly recommended to secure long-term protection against fracture after teriparatide treatment.
-
5.
[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.
-
6.
Design of a pragmatic approach to evaluate the effectiveness of concurrent treatment for the prevention of osteoporotic fractures: rationale, aims and organization of a Japanese Osteoporosis Intervention Trial (JOINT) initiated by the Research Group of Adequate Treatment of Osteoporosis (A-TOP).
Shiraki, M, Kuroda, T, Miyakawa, N, Fujinawa, N, Tanzawa, K, Ishizuka, A, Tanaka, S, Tanaka, Y, Hosoi, T, Itoi, E, et al
Journal of bone and mineral metabolism. 2011;(1):37-43
Abstract
The aim of osteoporosis treatment is to prevent future fractures. Although concurrent treatment has been used very frequently for osteoporosis in clinical practice, there are no data on accurate and verified effectiveness of concurrent treatment for fracture prevention in patients with osteoporosis. To clarify the clinical usefulness of concurrent treatment, the Japan Osteoporosis Society has authorized the establishment of the A-TOP (Adequate Treatment of Osteoporosis) research group. The objective of this research is to establish a design for a clinical trial to prove whether concurrent treatment using both alfacalcidol (1-alpha-hydroxycholecalciferol) and alendronate is more effective as compared to treatment using alendronate alone in terms of fracture prevention. The present study was named JOINT (Japanese Osteoporosis Intervention Trial) and is based on a method using national, prospective, randomized, open-labeled, blinded endpoints focusing on postmenopausal osteoporosis with a high risk for fracture. The patients were mainly selected by practitioners and allocated randomly by a central registration system into two groups, of which one received 5 mg/day of alendronate alone, and the other received 1 μg/day of 1-alpha-hydroxycholecalciferol (alfacalcidol) in addition to the alendronate. The endpoints focused primarily on fracture prevention, and the patients' quality of life (QOL) and change in body height, as well as adherence and the adverse events of the treatments were evaluated secondarily. To obtain sufficient statistical power in the events during a 2-year observation period, the patients who are expected to have higher risk were selected to participate in this study, and it was decided that the final plan would involve 890 patients per group (two-sided alpha = 0.05, power = 0.8). Data collection began in November 2003. Correspondence regarding the registration of the investigator and the progress of the study was conducted through a web system from the Public Health Research Foundation to practitioners.
-
7.
[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.