Efficacy and safety of romosozumab among Japanese postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease.

Introduction: This post hoc analysis of the placebo-controlled phase 3 FRAME study assessed the efficacy and safety of romosozumab in a subpopulation of Japanese postmenopausal women with osteoporosis and chronic kidney disease (CKD).

Materials And Methods: Data were analyzed by baseline estimated glomerular filtration rate (eGFR), where < 90 mL/min/1.73 m denoted CKD and ≥ 90 mL/min/1.

Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial.

Introduction: This post-hoc analysis of the FRAME study investigated the long-term efficacy and safety of romosozumab followed by denosumab in postmenopausal Japanese women with osteoporosis at high fracture risk.

Materials And Methods: Data from Japanese women with a high fracture risk participating in the international, randomised, double-blind, placebo-controlled, phase 3 FRAME study were analysed. High risk of fracture was defined as ≥ 1 fragility fracture with bone mineral density (BMD) ≤ - 2.

Functional data analysis applied to a randomized controlled clinical trial in hemodialysis patients describes the variability of patient responses in the control of renal anemia.

The achievement of desirable hemoglobin levels in renal anemia that is treated with epoetins is often incomplete and subject to much variation of outcome values and applied dosage. The further development of clinical decision support for renal anemia requires the characterization of patient responses and an analysis of the dynamics of the dosage and response variables. In this methodologic article, the extended data of a randomized, controlled clinical trial comparing two epoetins were examined by the techniques of functional data analysis to establish how precisely the patterns of treatment response might be described and analyzed.

Development and exploitation of a clinical decision support system for the management of renal anaemia.

The management of renal disease and its comorbidities lends itself to the use of computer-assisted decision support systems (CDSS); however, several issues with regard to computer-based treatment algorithms remain unresolved. This review examines the development and application of a clinical decision support system for the management of renal anaemia. Studies illustrate the dependence of outcome on prespecified haemoglobin (Hb) intervention values (thresholds) and the use of a computer program containing treatment algorithms to manage Epoetin doses and iron supplements.

Structured conversion from thrice weekly to weekly erythropoietic regimens using a computerized decision-support system: a randomized clinical study.

In view of the recent interest in weekly erythropoietic regimens and the lack of studies directly comparing the available agents, the clinical effectiveness of darbepoetin-alpha (DA) and epoetin-beta (EB), when administered via the subcutaneous route on a weekly basis, after conversion from thrice-weekly subcutaneous EB, was studied. In this 9-mo, single-center, randomized study of an unselected hemodialysis population, anemia was managed with a computerized decision-support system. Per-protocol analysis of the 81 patients in each arm who completed the study showed similar hemoglobin outcomes between treatment arms, both at randomization and at the end of the study.