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

June 27, 2019 updated by: Ioannis K. Triantafyllopoulos, MD,MSci,PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Calcium, vitamin D and bioactive collagen peptides supplement
In this arm, all patients received a sachet containing 5mg bioactive collagen peptides, 500 mg calcium lactate and 400 IU vitamin D3 per day.
Dietary supplement: Calcium, vitamin D and bioactive collagen peptides supplement
Active Comparator: Calcium and vitamin D supplement
In this arm, all patients received a chewable tablet containing 500 mg calcium carbonate and 400 IU vitamin D3 per day.
Dietary supplement: Calcium and vitamin D supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of %-changes of P1NP and CTX levels from baseline to 3 months of supplementation between the two groups.
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ioannis K. Triantafyllopoulos, MD,MSci,PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2017

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84908/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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