Osteopenia Clinical Trial
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
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.
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