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

Not Applicable

• Conditions: Osteopenia; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616001117404
• Lead Sponsor: ROUSSELOT SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the change between 0 and 12 months of lumbar spine (L1-L4) bone mineral density (g/cm^2) assessed by Dual-energy X-ray absorptiometry (DXA).[Baseline and 12 months]

Secondary Outcome Measures

Name	Time	Method
Change between 0 and 12 months of total hip bone mineral density (g/cm^2) assessed by DXA [Baseline and 12 months];Change between 0 and 12 months of femoral neck bone mineral density (g/cm^2) assessed by DXA[Baseline and 12 months];Change between 0 and 12 months of great trochanter bone mineral density (g/cm^2) assessed by DXA [Baseline and 12 months];Change between V1 and V3 visits serum bone turnover markers CTX (pg/mL) and P1NP (ng/mL);<br>This is a composite outcome[Baseline and 12 months];Change between V1 and V3 visits of SF-36 subscores [Baseline and 12 months]