Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001117404
Ethics application status
Approved
Date submitted
13/07/2016
Date registered
17/08/2016
Date last updated
23/08/2016
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 289644 0
None
Universal Trial Number (UTN)
Trial acronym
PROBONE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia 299440 0
Condition category
Condition code
Musculoskeletal 299421 299421 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295261 0
Prevention
Intervention code [2] 295632 0
Treatment: Other
Comparator / control treatment
The placebo is maltodextrin which has very similar characteristics, appaerance and is packaged in an identical manner.
Control group
Placebo

Outcomes
Primary outcome [1] 298889 0
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).
Timepoint [1] 298889 0
Baseline and 12 months
Secondary outcome [1] 325549 0
Change between 0 and 12 months of total hip bone mineral density (g/cm^2) assessed by DXA
Timepoint [1] 325549 0
Baseline and 12 months
Secondary outcome [2] 325550 0
Change between 0 and 12 months of femoral neck bone mineral density (g/cm^2) assessed by DXA
Timepoint [2] 325550 0
Baseline and 12 months
Secondary outcome [3] 325551 0
Change between 0 and 12 months of great trochanter bone mineral density (g/cm^2) assessed by DXA
Timepoint [3] 325551 0
Baseline and 12 months
Secondary outcome [4] 325563 0
Change between V1 and V3 visits serum bone turnover markers CTX (pg/mL) and P1NP (ng/mL);
This is a composite outcome
Timepoint [4] 325563 0
Baseline and 12 months
Secondary outcome [5] 325565 0
Change between V1 and V3 visits of SF-36 subscores
Timepoint [5] 325565 0
Baseline and 12 months

Eligibility
Key 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
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to one of the two groups using a random-generator computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment outside Australia
Country [1] 8021 0
France
State/province [1] 8021 0

Funding & Sponsors
Funding source category [1] 294035 0
Commercial sector/Industry
Name [1] 294035 0
ROUSSELOT SAS
Country [1] 294035 0
France
Primary sponsor type
Commercial sector/Industry
Name
ROUSSELOT SAS
Address
4 rue de l'abreuvoir 92400 Courbevoie FRANCE
Country
France
Secondary sponsor category [1] 292856 0
None
Name [1] 292856 0
Address [1] 292856 0
Country [1] 292856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295448 0
CPP Ouest VI - Brest
Ethics committee address [1] 295448 0
CHU Cavale Blanche
Avenue Tanguy Prigent
29609 Brest Cedex
Ethics committee country [1] 295448 0
France
Date submitted for ethics approval [1] 295448 0
17/05/2016
Approval date [1] 295448 0
26/07/2016
Ethics approval number [1] 295448 0

Summary
Brief summary
The aim of the study is to assess the effects of a hydrolyzed collagen on bone mineral density assessed by Dual-enegy X-ray absorptiometry (DXA) and bone metabolism in healthy postmenopausal women with osteopenia.
This study is designed as a monocentric randomized, double-blind, placebo-controlled clinical trial with 2 parallel groups.
There is a screening visit (V0) followed by a randomization visit (V1) which takes place four to ten weeks after V0. The experimental phase with placebo or verum product then lasts 12 months. One intermediate follow-up visit (V2) is planned after 6 months of consumption and the end of study visit is performed after 12 months of consumption (V3).
144 healthy postmenopausal women with osteopenia will be recruited for this study, according to the following inclusion and exclusion criteria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67246 0
Dr Dr David Gendre
Address 67246 0
Clinical Investigation Center - Biofortis
Dr David Gendre
3 route de la chatterie
44800 Saint Herblain
Country 67246 0
France
Phone 67246 0
+33240205799
Fax 67246 0
Email 67246 0
[email protected]
Contact person for public queries
Name 67247 0
Janne PRAWITT
Address 67247 0
Rousselot
Mme Janne Prawitt
4 rue de l'abreuvoir
92400 Courbevoie
Country 67247 0
France
Phone 67247 0
+32 (0)490 658 146
Fax 67247 0
Email 67247 0
[email protected]
Contact person for scientific queries
Name 67248 0
Janne PRAWITT
Address 67248 0
Mme Janne PRAWITT
Rousselot SAS
4 rue de l'abreuvoir
92400 Courbevoie
Country 67248 0
France
Phone 67248 0
+32 (0)490 658 146
Fax 67248 0
Email 67248 0
[email protected]

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No Supporting Document Provided



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