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
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
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
NCT ID
NCT03999775
First Posted
June 25, 2019
Last Updated
June 27, 2019
Sponsor
Ioannis K. Triantafyllopoulos, MD,MSci,PhD
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
Learn more about this trial
Effect of Calcium and Vitamin D Supplementation With and Without Collagen Peptides in Postmenopausal Women With Osteopenia
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