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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001117404
• Date of registration: 17/08/2016
• Prospective Registration: Yes
• Primary sponsor: ROUSSELOT SAS
• Public title: Effects of a hydrolyzed collagen on bone mineral density and bone metabolism in healthy postmenopausal women with osteopenia.
• Scientific title: Effects of a hydrolyzed collagen on bone mineral density and bone metabolism in healthy postmenopausal women with osteopenia.
• Date of first enrolment: 01/09/2016
• Target sample size: 144
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616001117404.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

France

Contacts

• Name: Mrs Janne PRAWITT

• Name: Mrs Janne PRAWITT

Key inclusion & exclusion criteria

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

Age minimum: 45 Years
Age maximum: 65 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Osteopenia;
Osteopenia

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

After randomization, the volunteer will take one sachet of hydrolyzed collagen or placebo daily at dinner, during a period of 12 months (from visit V1 to visit V3).
The 10 mg sachet can be dissolved in a cold or warm drink or mixed into a food such as a yoghurt.

Product compliance will be evaluated at V2 and V3 in order to check that all included subjects respect the study protocol with respect to the consumption of the study product. To evaluate the compliance, subjects will be asked to bring the non-consumed product sachets at V2 and V3.

Primary Outcome(s)

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(s)

Change between V1 and V3 visits serum bone turnover markers CTX (pg/mL) and P1NP (ng/mL);
This is a composite outcome[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 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 V1 and V3 visits of SF-36 subscores [Baseline and 12 months]

Secondary ID(s)

None

Source(s) of Monetary Support

ROUSSELOT SAS

Ethics review

Status: Approved
Approval date:
Contact:

CPP Ouest VI - Brest