The effect of effervescent and buffered alendronate on bone turnover compared to conventional alendronate: A randomized non-inferiority trial

Aarhus University Hospital0 个研究点目标入组 64 人开始时间: 2020年12月3日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•Sixty-four postmenopausal women with BMD T-score < -1 osteopenia and high bone turnover.
•-2 years since last menstrual bleeding
•-Bone mineral density T-score < -1 at either lumbar spine or hip
•-CTx > 0.42 µg/L
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 34

•-Ever treatment for osteoporosis
•-Indication for teriparatide treatment
•-Treatment with oral systemic glucocorticoids within last 12 months
•-Rheumatoid arthritis
•-Inflammatory bowel disease
•-Untreated thyroid disease
•-Primary hyperparathyroidism
•-Diabetes mellitus
•-eGFR < 60 mL/min
•-Cancer within last 2 years except basal cell carcinoma of the skin
•-Hormone therapy
•-Unstable liver disease
•-Contraindications for alendronate
•-Major gastrointestinal disease within 12 months (eg. esophagitis, ulcer, major surgery).
•-Vitamin D < 50nmol/L

发起方

Aarhus University Hospital