title: Safety and efficacy of polycalcium for improving biomarkers of bone metabolism: a 4-week open-label clinical study.
abstract: Polycalcium is a mixture of Polycan and calcium lactate-gluconate 1:9 (w/w) with demonstrated antiosteoporosis activity in vitro and in vivo studies. These studies were a 4-week open-label, single-center trial to evaluate the efficacy of oral Polycalcium on bone metabolism and safety. In total, 30 healthy women (range 40-60 years) were administered 400 mg of Polycalcium for 4 weeks. The primary efficacy parameter was urinary deoxypyridinoline (DPYR) levels, and serum osteocalcin (OSC), bone-specific alkaline phosphatase (BALP), urinary cross-linked C-telopeptide of type-1 collagen (CTx), urinary cross-linked N-telopeptide of type-1 collagen (NTx), calcium (Ca), and phosphorus (P) levels, which were evaluated for comparison before and after administration of Polycalcium. After 4 weeks of Polycalcium administration, 27 subjects completed the test plan. Three subjects withdrew their consent to participate. The values of blood OSC, BALP, serum Ca, and serum P from baseline to 4 weeks of treatment were changed by -28.44%, 14.37%, 6.11%, and 1.42%, respectively. Biomarkers of bone resorption: urinary DPYR, serum CTx, serum NTx, urinary Ca, and urinary P, at baseline after 4 weeks of treatment were changed by -13.40%, 6.67%, -5.13%, -22.43%, and -3.04%, respectively. Additionally, when considering the subjects' adverse effects and the results of the blood and urine tests over the 4-week trial period, the dose of 400  mg Polycalcium showed efficacy for improving bone metabolism and was well tolerated and safe. Polycalcium was apparently safe and efficacious.
authors.affiliation: RIS Center, Industry-Academic Cooperation Foundation, Silla University, Busan, Republic of Korea.
authors.forename: Jae-Suk
authors.initials: JS
authors.lastname: Choi
authors.forename: Mi-Yeon
authors.initials: MY
authors.lastname: Park
authors.forename: Jong-Dae
authors.initials: JD
authors.lastname: Kim
authors.forename: Hyung Rae
authors.initials: HR
authors.lastname: Cho
authors.forename: In Soon
authors.initials: IS
authors.lastname: Choi
authors.forename: Joo-Wan
authors.initials: JW
authors.lastname: Kim
mesh_terms: D000328:Adult; D000469:Alkaline Phosphatase / Q000378:metabolism; D000596:Amino Acids / Q000652:urine; D001203:Ascomycota / Q000737:chemistry; D001688:Biological Products / Q000494:pharmacology / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood / Q000652:urine; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001862:Bone Resorption / Q000517:prevention & control; D001842:Bone and Bones / Q000187:drug effects* / Q000378:metabolism; D002118:Calcium / Q000097:blood / Q000494:pharmacology / Q000627:therapeutic use* / Q000652:urine; D017610:Calcium Compounds / Q000494:pharmacology / Q000627:therapeutic use*; D002125:Calcium Gluconate / Q000494:pharmacology / Q000627:therapeutic use*; D024042:Collagen Type I / Q000097:blood / Q000652:urine; D005260:Female; D006801:Humans; D007773:Lactates / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D010024:Osteoporosis / Q000097:blood / Q000517:prevention & control* / Q000652:urine; D010455:Peptides / Q000097:blood / Q000652:urine; D010758:Phosphorus / Q000097:blood / Q000652:urine; D016896:Treatment Outcome; D047071:beta-Glucans / Q000627:therapeutic use*
chemical_list: D000596:Amino Acids; D001688:Biological Products; D015415:Biomarkers; D050071:Bone Density Conservation Agents; D017610:Calcium Compounds; D024042:Collagen Type I; D007773:Lactates; D010455:Peptides; D047071:beta-Glucans; C052929:collagen type I trimeric cross-linked peptide; D015675:Osteocalcin; D010758:Phosphorus; C110051:calcium lactate; C036020:deoxypyridinoline; D000469:Alkaline Phosphatase; D002125:Calcium Gluconate; D002118:Calcium