NCT01478724

Brief Summary

Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis is a serious public health problem that is responsible for approximately 3 million women with osteoporosis in France, with approximately 150,000 cases per year occurring in vertebral fractures, of which only one third would be diagnosed and 50,000 hip fractures (causing death in 20% of cases). The frequency of the disease increases with age, particularly among women: 10% among women aged 60 years and 20% among women aged 65 and 40% among women aged 75. At menopause, oestrogen deficiency causes alterations of the immune system, decreased bone formation, microarchitectural deterioration and a decrease in bone mass. Various factors may contribute to this decrease in bone density such as diet, lifestyle, or the genetic background. According to prospective studies, an overexpression of 135% of hip fractures is expected at European level in 50 years. Therefore, it is interesting to develop new prevention approaches aimed at maintaining the healthy aging population. Nutritional researches can consider setting up a real prevention. Studies suggest that specific milk protein fraction contain factors able to promote bone formation, inhibit bone resorption in vitro. In animal model, they showed that the specific fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption. Furthermore, in human volunteers, a supplementation with the specific milk protein fraction maintains balanced bone remodelling and increase bone mineral density. For example, in healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p\<0.05). The objective of this study is to assess the efficacy of daily consumption of the milk proteins fraction on bone mineral density improvement in healthy postmenopausal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

3.5 years

First QC Date

November 21, 2011

Last Update Submit

May 22, 2015

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • lumbar spine bone mineral density

    24 months

Secondary Outcomes (3)

  • femoral bone mineral density

    12 and 24 months

  • lumbar spine bone mineral density

    12 months

  • bone remodelling biomarkers

    6 and 12 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Animal proteins

Dietary Supplement: Milk proteins fraction

Milk protein fraction dose 1

EXPERIMENTAL
Dietary Supplement: Milk proteins fraction

Milk protein fraction dose 2

EXPERIMENTAL
Dietary Supplement: Milk proteins fraction

Interventions

Milk proteins fractionDIETARY_SUPPLEMENT

capsules, one per day, 24 months

Milk protein fraction dose 1Milk protein fraction dose 2Placebo

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasian Female
  • Natural or surgical menopause between 1 and 5 years
  • Aged between 50 to 65 years
  • BMI between 19 and 30 kg/m²

You may not qualify if:

  • Medications: oral steroidal anti-inflammatory, anti-osteoporotic treatment, hormone replacement therapy
  • Low bone mineral density (T-score\<-3
  • Diseases affecting bone metabolism(Paget's disease, Cushing's disease, thyroid disease...)
  • Intolerance or allergy to milk proteins and allergy to soy or soy lecithin
  • Heavy smoking
  • Excessive alcohol drinking
  • Intensive sports practice according to the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Christian Roux, PUPH

    Cochin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations

FR(1)