SummaryThis study compares efficacy of ALN/D5600 versus that of calcitriol in osteoporotic Chinese postmenopausal women. ALN/D5600 produced greater bone mineral density (BMD) increases, greater bone turnover marker decreases, and less vitamin D insufficiency. This study provided detailed clinical information regarding ALN/D5600 treatment versus calcitriol 0.25 μg/day. The study did not evaluate fracture risk.IntroductionThe aim of this study is to investigate efficacy of alendronate 70 mg/vitamin D3 5600 IU combination tablets (ALN/D5600) versus calcitriol in osteoporotic Chinese postmenopausal women.MethodsThis study is a 6-month, randomized, open-label, active-comparator study with 6-month extension (clinicaltrials.gov number NCT01350934) in postmenopausal women aged >55 years with osteoporosis (low bone mineral density (BMD) with/without prior fragility fracture). Patients were randomized to ALN/D5600 once weekly or calcitriol 0.25 μg daily. The primary efficacy end point of the base study was percent change from baseline in lumbar spine BMD (month 6). Hypercalcemia and hypercalciuria were safety events of special interest.ResultsA total of 219 patients (ALN/D5600 n = 111, calcitriol n = 108) were randomized. Baseline characteristics were similar, 30.3 % baseline 25-hydroxyvitamin D (25(OH)D) ≤15 ng/mL. At months 6 and 12, changes in lumbar spine BMD from baseline were 3.5 versus 1.6 % and 5.2 versus 2.3 % for ALN/D5600 versus calcitriol (between-group differences p < 0.001), respectively. Between-group differences for ALN/D5600 versus calcitriol were significant (p < 0.001) at months 6 and 12 for change from baseline in procollagen type 1 N-terminal propeptide (−59.1 versus −16.8 %, −68.1 versus −17.0 %) and serum C-telopeptides (−79.2 versus −27.2 %, −76.2 versus −24.2 %). Drug-related adverse events (AEs) and discontinuations due to drug-related AEs occurred in 15 (14.0 %) versus 8 (7.4 %) patients and 3 (2.8 %) versus 0 patients in the ALN/D5600 and calcitriol group, respectively. Hypercalciuria 12-month incidence (24-h urine Ca >300 mg) was 8.4 (ALN/D5600) versus 13.9 % (calcitriol) (p > 0.05). One patient (calcitriol) had hypercalcemia.ConclusionsALN/D5600 produced greater increases in lumbar spine BMD and greater decreases in bone turnover markers versus calcitriol in osteoporotic Chinese women. It is not known whether the greater increase in BMD results in fewer fractures. ALN/D5600 was generally well tolerated in Chinese patients.

Objective: To investigate changes in the immature teeth of Sprague-Dawley rats during orthodontic treatment and to explore the changes in the peri-radicular alveolar bone through micro-computed tomography (CT). Methods: Twentyfive 26-day-old male Sprague-Dawley rats were included. The maxillary left first molar was moved mesially under a continuous force of 30 cN, and the right first molar served as the control. After orthodontic treatment for 7, 14, 21, 28, and 42 days, the root length, tooth volume, and alveolar bone mineral density (BMD) around the mesial root were measured through micro-CT. Results: The immature teeth continued to elongate after application of orthodontic force. The root length on the force side was significantly smaller than that on the control side, whereas the differences in the volume change between both sides were not statistically significant. Alveolar bone in the coronal part of the compression and tension sides showed no difference in BMD between the experimental and control groups. The BMD of the experimental group decreased from day 14 to day 42 in the apical part of the compression side and increased from day 7 to day 42 in the apical part of the tension side. The BMD of the experimental group decreased in the root apex part on day 7. Conclusions: The root length and volume of immature teeth showed continued development under orthodontic forces. Alveolar bone resorption was observed on the compression side, and bone formation was observed on the tension side.

EPDS) during the postnatal period. Data were collected in home-visit provided by public health nurses at the first month and the regular health-check at the fourth and the seventh month after giving birth. The effectiveness of the intervention was based on clinical evidence as measured by EPDS, and improvements in maternal quality of life were estimated by mapping EPDS to the utility scores. Costs were derived from the annual budget for the maternal and child health service in the local authority. Cost-effectiveness was calculated as the incremental cost per QALY gained. Results: A total of 464 mothers who gave birth during November 2015 to April 2016 was analyzed. The EPDS score and the utility score were 4.026 (SD: 4.002) and 0.898 (SD: 0.125), respectively. Among all the models considered for the mapping, the ordinary least squares (OLS) linear model was selected because of higher accuracy (Root MAE=0.1138). Compared to that of mothers with postnatal mental disorders (EPDS scored 9 or above), the utility score of those counterparts were 0.105 QALY higher. The estimated ICER of the strengthened intervention program was 294,917.79 JPY per QALY gained. Conclusions: The strengthened community-based intervention program is highly cost-effective and leads to improved quality of life through a reduction in postnatal depression.