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Objectives@#To assess differences in efficacy of a 28.2-μg teriparatide formulation for twice-weekly use (2/W-TPTD) by patient characteristics. @*Methods@#A post hoc analysis was performed using data from a multicenter, randomized, double-blind, double-dummy, non-inferiority trial (TWICE study) conducted in Japan comparing the efficacies of once-weekly and twice-weekly injections of teriparatide (TPTD). Specifically, a stratified analysis of percentage changes from baseline was performed using the final data on lumbar spine bone mineral density (BMD) after a 48-week treatment period (n = 251, 2/W-TPTD; n = 239, a 56.5-μg teriparatide formulation for once-weekly use [1/W-TPTD]). @*Results@#Across all subgroups defined by patient characteristics that included 9 or more subjects, the lumbar spine BMD increased significantly in both groups. In the 2/W-TPTD group, the percentage change was significantly higher in subjects with no non-vertebral fractures without large external force occurring at or after age 50 years versus those with such fractures. The lower the stratification in baseline lumbar spine BMD, total hip BMD, or femoral neck BMD, the greater was the percentage change. @*Conclusions@#Whereas all subgroups can expect a significant improvement in lumbar spine BMD, there were some patient characteristics that affected the percentage increase in BMD.
ABSTRACT
Objectives@#To assess differences in efficacy of a 28.2-μg teriparatide formulation for twice-weekly use (2/W-TPTD) by patient characteristics. @*Methods@#A post hoc analysis was performed using data from a multicenter, randomized, double-blind, double-dummy, non-inferiority trial (TWICE study) conducted in Japan comparing the efficacies of once-weekly and twice-weekly injections of teriparatide (TPTD). Specifically, a stratified analysis of percentage changes from baseline was performed using the final data on lumbar spine bone mineral density (BMD) after a 48-week treatment period (n = 251, 2/W-TPTD; n = 239, a 56.5-μg teriparatide formulation for once-weekly use [1/W-TPTD]). @*Results@#Across all subgroups defined by patient characteristics that included 9 or more subjects, the lumbar spine BMD increased significantly in both groups. In the 2/W-TPTD group, the percentage change was significantly higher in subjects with no non-vertebral fractures without large external force occurring at or after age 50 years versus those with such fractures. The lower the stratification in baseline lumbar spine BMD, total hip BMD, or femoral neck BMD, the greater was the percentage change. @*Conclusions@#Whereas all subgroups can expect a significant improvement in lumbar spine BMD, there were some patient characteristics that affected the percentage increase in BMD.
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Objectives@#On July 20, 2012, the European Medicines Agency (EMA) provided a recommendation that limits the long-term use of calcitonin. Based on this recommendation, we investigate the presence or absence of a cancer diagnosis in subjects who participated in the ongoing clinical trial of elcatonin. @*Methods@#When the EMA gave this recommendation, we were conducting “a 3-year placebo-controlled clinical study for elcatonin” (hereinafter, referred to as “the original study”). In accordance with the recommendation of EMA, we performed an intermediate analysis on the subjects of the original study to assess whether the study could be safely continued. We also added a 2-year follow-up study to investigate the risk of carcinogenesis for 5 years from the start of administration. We compared the risk of carcinogenesis estimated by person-year method in elcatonin group with that in placebo group. @*Results@#In the original study, there were 433 subjects in the elcatonin group and 437 in the placebo group, of whom 322 and 323, respectively, agreed to participate in the additional follow-up study. The average cancer incidence rate per 100 person-years 5 years from the start of administration was 1.02 in the elcatonin group and 1.08 in the placebo group, respectively, and there was no clear difference. @*Conclusions@#Since the number of cases in this study was small, we cannot completely deny the cancer risk due to long-term administration of this drug. However, the results do not suggest that once-weekly administration of 20 units of elcatonin increases the carcinogenic risk.
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Objectives@#On July 20, 2012, the European Medicines Agency (EMA) provided a recommendation that limits the long-term use of calcitonin. Based on this recommendation, we investigate the presence or absence of a cancer diagnosis in subjects who participated in the ongoing clinical trial of elcatonin. @*Methods@#When the EMA gave this recommendation, we were conducting “a 3-year placebo-controlled clinical study for elcatonin” (hereinafter, referred to as “the original study”). In accordance with the recommendation of EMA, we performed an intermediate analysis on the subjects of the original study to assess whether the study could be safely continued. We also added a 2-year follow-up study to investigate the risk of carcinogenesis for 5 years from the start of administration. We compared the risk of carcinogenesis estimated by person-year method in elcatonin group with that in placebo group. @*Results@#In the original study, there were 433 subjects in the elcatonin group and 437 in the placebo group, of whom 322 and 323, respectively, agreed to participate in the additional follow-up study. The average cancer incidence rate per 100 person-years 5 years from the start of administration was 1.02 in the elcatonin group and 1.08 in the placebo group, respectively, and there was no clear difference. @*Conclusions@#Since the number of cases in this study was small, we cannot completely deny the cancer risk due to long-term administration of this drug. However, the results do not suggest that once-weekly administration of 20 units of elcatonin increases the carcinogenic risk.
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OBJECTIVES: To reassess the safety and efficacy of once-weekly teriparatide 56.5 mg in osteoporosis patients with a high fracture risk. METHODS: This postmarketing observational study was conducted at 72 weeks according to the package insert. Of the 3573 Japanese osteoporosis patients in the safety analysis set, 91.80% were women, the mean age was 78.1 years, and 69.89% had a history of prevalent fragility fractures, indicating that a high proportion of patients at high risk of fracture were enrolled. RESULTS: Persistence with weekly teriparatide treatment was 59.36%, and 38.95% at 24 and 72 weeks, respectively. Adverse drug reactions (ADRs) were reported in 898 patients (25.13%), and serious ADRs were reported in 26 patients (0.73%). The most frequent ADRs were nausea, vomiting, and headache. The cumulative incidence of new vertebral fractures 72 weeks after the start of treatment was 3.31%. Increases in the bone mineral density were observed in the lumbar spine, femoral neck, and proximal femur. The serum levels of the bone formation markers, procollagen type I N-terminal propeptide and bone-type alkaline phosphatase, increased slightly at 24 weeks and then decreased to baseline levels. At 24 and 72 weeks, the bone resorption markers, serum cross-linked N-terminal telopeptide of type I collagen and urinary cross-linked N-terminal telopeptide of type I collagen, were the same as or slightly lower than at baseline. Visual analogue scale scores for low back pain also decreased. CONCLUSIONS: The present results showed that once-weekly teriparatide may also be useful for osteoporosis patients with a high risk of fracture.
Subject(s)
Female , Humans , Alkaline Phosphatase , Asian People , Biomarkers , Bone Density , Bone Resorption , Collagen Type I , Drug-Related Side Effects and Adverse Reactions , Femur , Femur Neck , Headache , Incidence , Low Back Pain , Nausea , Observational Study , Osteogenesis , Osteoporosis , Product Labeling , Spine , Teriparatide , VomitingABSTRACT
The effects of the serum vitamin C levels on the activity and isozyme pattern of serum lactate dehydrogenase (LDH) in males and females in their middle and old age were examined.<BR>There was no siginificant correlation among the total serum, LDH activity and serum vitamin C levels in the 87 male and 83 female ranging from 45 to 84 years of age. However, high inverse correlations were found among the percentage of LDH-4 and LDH-5 and serum vitamin C levels all of age groups (45-59 years of age group, 60-69 years of age group and over 70 years of age group) of males and females.<BR>These results suggest that the percentage of LDH-4 and LDH-5 are influenced by the vitamin C intake in males and females in their middle and old age.
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For the preservation of health in rural areas, this paper reports on the variation of human serum lipids by intaking lentinus edodes.<BR>Serum lipids levels showed no significant change by intaking lentinus edodes that amounts of 20, 40 and 60g per day each for 5 days. From data of correlationship between serum lipid levels and nutrition intake of experimental diet, it was recognized that high-density-lipoprotein cholesterol level was directly proportional to carbohydrate-fat ratio significantly (p< 0.02), and was inversely proportional to fat intake, fat-protein ratio and carbohydrate-protein ratio significantly (p< 0.05), respectively. Triglycerides level was inversely proportional to protein intake significantly (p< 0.05).<BR>These results concluded that the decrease of serum cholesterol level by intaking of lentinus edodes in healthy young men whose serum cholesterol levels were in normal range was not recognized.
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This survey was conducted in a local city, Tokushima for its 23 administrative sections, which were classified into rural, non-rural and mixed districts based on the data related to agriculture. Complaints of public nuisances in these districts have been examined and the following findings have been obtained.<BR>1. Complaints about water pollution and offensive odor in the rural district and those about offensive odor and noise in the mixed district have been raised more often, respectively. While, in the non-rural district more complaints about noise have been raised. Thus, it is recognized that possible pollution phenomena vary depending on regional patterns.<BR>2. In time-serial comparison between the first half (1977-1980) and the second half (1981-1984) of survey period, it is found that total complaints of public nuisances have been reduced and the complaints in the rural district have been increased for all the types excepting dust. Therefore, it is suggested that regional environment in suburban farm villages has been deteriorating.
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Relationship between SGOT/SGPT ratio and energy intake were investigated in 1030 subjects (373 males, 657 females). These figures were taken from epidemiological survey of the Tokushima prefecture from 1975 to 1980.<BR>The results of the survey were as follows.<BR>1) Energy intakes in reversal group (SGOT/SGPT <1) was higher than that in nromal group (SGOT/SGPT >1).<BR>2) Body weight in reversal group was higher than that in normal group except young woman (18-39 years).<BR>3) Incidence of reversal of SGOT/SGPT ratio showed increasing values as energy intakes levels increased.<BR>It is possible to conclude from the results that SGOT/SGPT ratio was affected by energy intakes.
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This paper reports the changes in the activity and isozyme pattern of serum LDH in healthy young men given a low protein diet (0.73-0.75/kg body weight; 40-50g/day) for 21 days.<BR>Serum total LDH activity showed no significant change in eight healthy young volunteers who received low protein diet for 21 days. However, the percentages of LDH-5 and LDH-4 increased significantly (P<0.01) from basal levels of 5.9±2.3 and 7.1±1.4 to 10.6±2.9% and 10.1±0.9%, respectively on day 14.<BR>These results suggest that measurements of the percentages of LDH-4 and LDH-5 isozymes can be used to evaluate the protein intake, but serum LDH activity cannot be used as an index of nutrition.
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The purpose of the present paper is to explore the relationships between the activity and fraction ratio of serum γ-GTP and the dietary intake of nutrients through three groups (lean, normal and overweight) by Broca's index. Broca's index in each groups was under 89 for the lean group, from 90to 109 for the normal group and over 110 for the overweight group. The subjects of study were 249 young healthy men except alcoholic.<BR>Results of the survey were as follows:<BR>1) There were statistically significant correlation between serum total γ-GTP activity in normal group and vitamin C intake (P<0.05).<BR>2) High negative correlations were observed between the fraction ratio of serum γ-GTP (1) and the vitamin B 1 intake (P<0.01), between the fraction ratio of serum γ-GTP (1) and vitamin C intake (P<0.01), and between the fraction ratio of serum γ-GTP (1) and the protein intake/kg of body weight (P<0.01) in the lean group. High negative correlations were observed between the fraction ratio of serum γ-GTP (1) and the protein intake (P<0.01), between the fraction ratio of serum y -GTP (1) and the vitamin B 1 intake (P<0.01), between the fraction ratio of serum γ-GTP (1) and vitamin C intake (P<0.01), and between the fraction ratio of serum γ-GTP (1) and the protein intake/kg of body weight (P<0.01) in the normal group. High negative correlation was observed between the fraction ratio of serum γ-GTP (1) and the vitamin C intake (P<0.01) in the overweight group.<BR>3) Multiple regression analysis showed that the variables which correlated best with the fraction ratio of serum γ-GTP (1) were dietary intakes of the energy, the vitamin C and the protein intake/kg of body weight in the lean group. The fraction ratio of serum γ-GTP (1) related to the vitamin C intake and the protein intake/kg of body weight in the normal group. In the overweight group, the fraction ratio of serum γ-GTP (1) related to the vitamin C intake and the animal protein intake.
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The purpose of this study is to make clear comprehensive relationship between Thymol turbidity test values (TTT) and the dietary intakes of nutrients. The subjects of this study were 287 young healthy people in Tokushima prefecture.<BR>The results of the survey were as follows:<BR>1) In males, multiple regression analysis showed that variables which correlated best with the TTT values were dietary intakes of sugar energy and vegetable protein aged 30-49 years, and dietary intakes of animal fat and energy aged 50-69 years.<BR>2) In females, multiple regression analysis showed that variables which correlated best with TTT values were dietary intakes of animal protein and vegetable fat aged 50 69 years, but there were no statistically significant correlation between TTT values and the dietary intakes of nutrients aged 30-49 years.
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The purpose of this study is to make clear a comprehensive relationship between two groups of serum enzyme activity and nutrient intakes. The first group of measurement include serum GOT, GPT, ALP activity and the second group of measurements include protein, fat, carbohydorate, vitamin A, B1, B2, C, animal protein, animal fat, age, and weight.<BR>These figures are taken from the epidemiological survey of Tokushima prefecture, including 252 males and 383 females, investigated from 1975 to 1980.<BR>Appling the canonical correlation analysis, we found the following results.<BR>1) In male, only two canonical correlations were statistically significant. The serum GOT and GPT activity related to body weight, further serum GOT activity was effected quality of food intakes.<BR>2) In Female, three canonical correlations were statistically significant. Both serum GOT and GPT activity related to protein intakes. High correlations were observed between serum GOT activty and vitamin B1, between serum GPT activity and vitamin C, between serum ALP activity and age.
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The purpose of this study is to make clear a comprehensive relationship between two groups of blood properties and nutrient intakes. The first group of measurement include hemoglobin contents, hematocrits and blood specific gravity and the second group of measurements includ energy, protein, fat, carbohydorate, vitamin A, B<SUB>1</SUB>, B<SUB>2</SUB>, C, animal protein, animal fat, iron, animal iron and age.<BR>These figures are taken from the epidemiological survey of Tokushima prefecture, including 301 males and 379 females, investigated from 1975 to 1980.<BR>Appling the canonical correlation analysis, we found the following results.<BR>1) In male, only canonical correlations were statistically significant. The hematocrit related strongly to carbohydorate, animal protein, fat intakes and age.<BR>2) In female, only canonical correlations were statisticall significant. Both hemoglobin contents and blood specific gravity effected carbohydorate and energy intakes.