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Effect of Calcium and Vitamin D Supplementation With and Without Collagen Peptides in Postmenopausal Women With Osteopenia

Primary Purpose

Osteopenia, Postmenopausal Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calcium, vitamin D and bioactive collagen peptides supplement
Calcium and vitamin D supplement
Sponsored by
Ioannis K. Triantafyllopoulos, MD,MSci,PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia focused on measuring Collagen peptides, Bone turnover markers, Calcium supplement, Postmenopausal women

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Postmenopausal women
  • T-score in the osteopenic range (-1.0 > T-score > -2.5) at either the lumbar spine (LS) or femur as measured by dual energy X-ray absorptiometry (DXA)

Exclusion Criteria:

  • T-score in the osteoporotic range (T-score < -2.5) at any site
  • Patients receiving supplements of calcium and/or vitamin D at that time or during the last year
  • Patients receiving medications known to positively or negatively affect bone turnover or BMD at that time or during the last 3 years (e.g. antiresorptive agents, oestrogens, systemic corticosteroids), or
  • Secondary cause of osteoporosis (e.g. alcohol abuse, thyrotoxicosis etc)
  • Patients who did not attend to their follow-up appointment and consequently had only the baseline measurements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Calcium, vitamin D and bioactive collagen peptides supplement

    Calcium and vitamin D supplement

    Arm Description

    In this arm, all patients received a sachet containing 5mg bioactive collagen peptides, 500 mg calcium lactate and 400 IU vitamin D3 per day.

    In this arm, all patients received a chewable tablet containing 500 mg calcium carbonate and 400 IU vitamin D3 per day.

    Outcomes

    Primary Outcome Measures

    Comparison of %-changes of P1NP and CTX levels from baseline to 3 months of supplementation between the two groups.
    The primary endpoint of the study was the comparison of %-changes of P1NP and CTX levels from baseline to 3 months of supplementation between the two groups.

    Secondary Outcome Measures

    Change of P1NP and CTX levels within groups and comparison of the adverse effects (tolerability), and/or the adherence to treatment between the two groups.
    The secondary endpoints were the change of P1NP and CTX levels following the 3-month calcium and vitamin D supplementation with and without collagen peptides supplement, the comparison of adverse effects (tolerability), and/or the adherence to treatment between the two groups.

    Full Information

    First Posted
    June 25, 2019
    Last Updated
    June 27, 2019
    Sponsor
    Ioannis K. Triantafyllopoulos, MD,MSci,PhD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03999775
    Brief Title
    Effect of Calcium and Vitamin D Supplementation With and Without Collagen Peptides in Postmenopausal Women With Osteopenia
    Official Title
    Effect on Bone Biomarkers and Bone Mineral Density and Tolerability of Calcium and Vitamin D Supplementation With and Without Collagen Peptides in Postmenopausal Women With Osteopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 14, 2017 (Actual)
    Primary Completion Date
    November 20, 2018 (Actual)
    Study Completion Date
    November 20, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ioannis K. Triantafyllopoulos, MD,MSci,PhD

    4. Oversight

    5. Study Description

    Brief Summary
    Osteoporosis is undoubtedly one of the most common diseases affecting older individuals with debilitating consequences. Osteopenia, defined as T-score between -1 and -2.5, has also been associated with increased risk of osteoporotic fractures and the associated morbidity and mortality. Prompt diagnosis, prevention and treatment of both osteopenia and osteoporosis are essential in order to minimize future fracture risk. The mainstay of treatment of osteopenia and osteoporosis includes dietary changes, regular weight-bearing exercises, calcium and vitamin D supplementation and pharmacologic treatment mainly with antiresorptive or anabolic agents. Collagen peptides (CPs), also called collagen hydrolysates produced by hydrolysis of collagen, have also been shown to have high oral bioavailability and could have a place as a treatment option. Type I collagen comprises approximately 95% of the entire collagen content of bone. Bone matrix, unlike other connective tissues, possesses the unique ability to become calcified. Spindle or plate-shaped crystals of hydroxyapatite are found between and around collagen fibers, oriented in the same direction as collagen fibers are. Nowadays, it is well-documented that type I collagen molecules are involved in the mechanical properties of bone. Collagen peptide compounds seem to exert their beneficial effect on bone by affecting bone remodeling and mineralization of the bone matrix, promoting the proliferation and differentiation of pre-osteoblasts while reducing the maturation of osteoclasts. Several preclinical studies performed in mice and rats support this notion and also suggested that orally administrated CPs increased bone mineral density (BMD), as well as the compositional and the biodynamic characteristics of vertebrae. Human studies in postmenopausal women have also yielded positive results with increased BMD and blood biomarkers after 6 months and 1 year of oral administration. The aim of the present randomized prospective study was to examine and compare the efficacy, as represented by the changes in bone biomarkers procollagen type I N-terminal propeptide (P1NP) and C-terminal telopeptide of collagen I (CTX), and bone mineral density and the tolerability of supplementation of calcium, vitamin D with and without bioactive CPs for a year in postmenopausal women with osteopenia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteopenia, Postmenopausal Osteopenia
    Keywords
    Collagen peptides, Bone turnover markers, Calcium supplement, Postmenopausal women

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Calcium, vitamin D and bioactive collagen peptides supplement
    Arm Type
    Active Comparator
    Arm Description
    In this arm, all patients received a sachet containing 5mg bioactive collagen peptides, 500 mg calcium lactate and 400 IU vitamin D3 per day.
    Arm Title
    Calcium and vitamin D supplement
    Arm Type
    Active Comparator
    Arm Description
    In this arm, all patients received a chewable tablet containing 500 mg calcium carbonate and 400 IU vitamin D3 per day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Calcium, vitamin D and bioactive collagen peptides supplement
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Calcium and vitamin D supplement
    Primary Outcome Measure Information:
    Title
    Comparison of %-changes of P1NP and CTX levels from baseline to 3 months of supplementation between the two groups.
    Description
    The primary endpoint of the study was the comparison of %-changes of P1NP and CTX levels from baseline to 3 months of supplementation between the two groups.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Change of P1NP and CTX levels within groups and comparison of the adverse effects (tolerability), and/or the adherence to treatment between the two groups.
    Description
    The secondary endpoints were the change of P1NP and CTX levels following the 3-month calcium and vitamin D supplementation with and without collagen peptides supplement, the comparison of adverse effects (tolerability), and/or the adherence to treatment between the two groups.
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Postmenopausal osteopenia
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Postmenopausal women T-score in the osteopenic range (-1.0 > T-score > -2.5) at either the lumbar spine (LS) or femur as measured by dual energy X-ray absorptiometry (DXA) Exclusion Criteria: T-score in the osteoporotic range (T-score < -2.5) at any site Patients receiving supplements of calcium and/or vitamin D at that time or during the last year Patients receiving medications known to positively or negatively affect bone turnover or BMD at that time or during the last 3 years (e.g. antiresorptive agents, oestrogens, systemic corticosteroids), or Secondary cause of osteoporosis (e.g. alcohol abuse, thyrotoxicosis etc) Patients who did not attend to their follow-up appointment and consequently had only the baseline measurements

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32131366
    Citation
    Argyrou C, Karlafti E, Lampropoulou-Adamidou K, Tournis S, Makris K, Trovas G, Dontas I, Triantafyllopoulos IK. Effect of calcium and vitamin D supplementation with and without collagen peptides on bone turnover in postmenopausal women with osteopenia. J Musculoskelet Neuronal Interact. 2020 Mar 3;20(1):12-17.
    Results Reference
    derived

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    Effect of Calcium and Vitamin D Supplementation With and Without Collagen Peptides in Postmenopausal Women With Osteopenia

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