Effects of a hydrolyzed collagen on bone mineral density and bone metabolism in healthy postmenopausal women with osteopenia.

ROUSSELOT SAS0 个研究点目标入组 144 人开始时间: 2016年8月17日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•caucasian female
•- natural surgical menopause or hormone replacement therapy stop ranging 1 and 5 years
•- low bone mineral density : T score greater than or equal to -2.5 at the lumbar spine (L1-L4);
•- low bone mineral density : T score less than or equal to -1 at the lumbar spine (L1-L4);
•- good general and mental health according to the investigator

•- T-score < -2.5 on hip total or femoral neck or great trochanter
•- Medications: oral steroidal anti-inflammatory, anti-osteoporotic treatment, hormone replacement therapy or other medications incompatible with the study according to the investigator (wash-out period above 6 months except for hormone replacement therapy: 1 year);
•- Presence of arthrosis that affects the ability to interpret the osteodensitometry
•- E4.Known Paget's disease, Cushing's disease, hyperparathyroidism, thyroid disease, sarcoidosis, chronic inflammatory bowel disease or chronic inflammatory diseases (rheumatoid arthritis, inflammatory bowel disease), renal lithiasis or any other disease that affects bone metabolism according to the investigator
•- Personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator
•- One or more low trauma fractures after age 45
•- Known non traumatic vertebral fracture
•- With significant change in food habits or in physical activity in the 3 months before randomization or not agreeing to keep them unchanged throughout the study
•- Heavy smoking (> 20 cig. / d); or planning to change his smoking habits throughout the study
•- Excessive alcohol drinking (> 21 drinks / week); or planning to change his alcohol consumption throughout the study

发起方

ROUSSELOT SAS