Open-label Study to Evaluate the Effect of MBP-80 on Bone Remodelling

NCT01501344 | Completed

• 2 other identifiers: 2010YogA80MBP-80 and Bone Remodelling
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine if daily oral intake of 200g of a marketed yogurt with fortified calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in postmenopausal women. The efficacy of the product is measured by examining the variation of biochemical markers of bone turnover. MBP 80 is a particular protein contained in milk; it has been added to the yogurt provided for this study. The effects of MBP 80 on the quality of bone tissue have not yet been proven.

Conditions

Postmenopausal Osteoporosis

Keywords

osteoporosis; postmenopausal women; bone remodelling; bone turnover markers

Outcome Measures

Primary Outcomes (1)

• Median percent change in levels of serum β CTX (sCTX), a bone resorption marker.

  The primary efficacy variable, the median percent change from baseline (Day 0) in levels of serum β-CTX (sCTX) at week 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum β-CTX (sCTX) at Day 0 for each participant.

  12 weeks

Secondary Outcomes (4)

• Median percent change in levels of P1NP, a bone formation marker.

  12 weeks

• Median percent change in levels of serum β-CTX (sCTX), a bone resorption marker

  4 weeks

• Median percent change in levels of urinary NTX(uNTX), a bone resorption marker.

  weeks 4 and 12

• Median percent change in levels of serum osteocalcin (sOC), a bone formation marker.

  12 weeks

Interventions

200 g yogurt with fortified calcium content and MBP 80 mg DIETARY_SUPPLEMENT

Intake of one container of vanilla or strawberry yogurt in the morning on a daily basis during 12 weeks.

Also known as: Yoplait Asana TM

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Early postmenopausal women, aged 45-60 yrs old inclusive, with 1-5 yrs since last menses; naturally or surgically menopausal as a result of bilateral oophorectomy. Hysterectomized (≤ 5 yrs) women 50-60 yrs old.
• Lumbar Spine (L.S.;L1-L4) BMD \> 0.772 g/cm2 (T-score of -2.5 on Hologic) and,
• Femoral Neck BMD \> 0.572 g/cm2 (T-score of -2.5 on Hologic) and,
• Total Hip BMD \> 0.637 g/cm2 (T-score of -2.5 on Hologic).
• Subjects must sign the Ethic Committee approved Informed Consent Form before any study procedure is initiated.

You may not qualify if:

• Any intake of calcium and vitamin D supplements including multivitamins, nutritional or dietary supplements of any kind containing calcium and vit D within 3 months prior to screening visit 1A.
• Daily dietary calcium intake \> 600 mg as assessed by the Calcium Intake Calculator (Appendix E).
• Subjects who already suffer from osteoporosis on the basis of a low BMD T-score ≤ - 2.5 at any site or a personal history of fragility fracture after age 40.
• Any past or present use of:
• Bisphosphonate
• PTH or PTH derivatives, eg. teriparatide
• Androgens, anabolic steroids or testosterone
• Tibolone
• Calcitriol
• Strontium ranelate
• Lithium, chronic warfarin or heparin use \> 3 months, anticonvulsants (benzodiazepines are allowed), gonadotrophin-releasing hormone agonists, glitazones.
• Administration of any of the following treatments within the last 3 months prior to screening:
• Glucocorticosteroids (\> 5 mg prednisone equivalent per day for \> 10 days)
• Systemic hormone replacement therapy
• Selective estrogen receptor modulators (SERMs), eg, raloxifene

Sponsors & Collaborators

• Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.: lead
• Aliments ULTIMA Foods Inc.: collaborator

Study Sites (1)

G.R.M.O. Inc.

Québec, Quebec, G1V 3M7, Canada

Location

Related Publications (31)

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MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Jacques P Brown, M.D.

  G.R.M.O. Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: December 29, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 9, 2012

Record last verified: 2011-12

Locations

CA (1)