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A calcium-collagen chelate dietary supplement attenuates bone loss in postmenopausal women with osteopenia: a randomized controlled trial

Marcus L. Elam, Sarah A. Johnson, Shirin Hooshmand, Rafaela G. Feresin, Mark E. Payton, Jennifer Gu, Bahram H. Arjmandi
Journal of Medicinal Food 2015 18(3):324–331

Bibliography

PubMed
PMID 25314004
DOI
10.1089/jmf.2014.0100
Funding
Funding statement (verbatim): "The funding and calcium-collagen chelate supplement (KoAct®) were provided by AIDP, Inc. (City of Industry, CA, USA)."
Competing interests
Author Disclosure Statement: Jennifer Gu is an employee of AIDP, Inc. No competing financial interests exist for the other authors. The study was also supported by an AIDP, Inc. grant-in-aid; that funding relationship is documented separately in the funding field.

Study snapshot

DesignRandomised, double-blind, active-controlled (calcium + vitamin D vs calcium-collagen chelate) parallel-group trial
ModelPostmenopausal women with DXA-confirmed osteopenia
Sample39 randomized (20 calcium-collagen chelate, 19 active control). At 6 months, 19 intervention and 19 control participants remained; only 22 completed the 12-month visit (12 intervention, 10 control). The paper reports both completer and intention-to-treat analyses.
InterventionCalcium-collagen chelate group: 5 g/day KoAct providing 500 mg elemental calcium plus 200 IU vitamin D3; active-control group: calcium carbonate providing 500 mg elemental calcium plus 200 IU vitamin D3. Study pills were administered as four pills twice daily for 12 months.
Duration12 months; DXA at baseline, 6 months, 12 months; blood biomarkers at baseline, 6, 12 months
EndpointsWhole-body BMD change at 12 months by DXA; Lumbar spine BMD change; Hip BMD change; Serum sclerostin; Serum TRAP5b; Serum bone-specific alkaline phosphatase (BAP); BAP/TRAP5b ratio

What the study showed, in plain terms

This 12-month randomized, double-blind active-controlled trial tested whether a calcium-collagen chelate could slow bone loss in postmenopausal women with osteopenia. Thirty-nine women were assigned to either 5 g/day of a calcium-collagen chelate (KoAct®; 500 mg elemental calcium plus 200 IU vitamin D) or a control providing the same calcium and vitamin D without the collagen component.

Whole-body bone mineral density declined in both groups, but the loss was smaller in the calcium-collagen-chelate group. The difference remained statistically significant in both completer and intention-to-treat analyses reported by the authors. At six months, the intervention group also showed lower sclerostin and TRAP5b and a higher bone-formation-to-resorption marker ratio.

The trial therefore suggests that this specific calcium-collagen-chelate formulation may reduce bone loss relative to calcium plus vitamin D alone in women with osteopenia. The study was small and industry-funded, and the tested product is a proprietary combination, so the result should not be generalized automatically to ordinary collagen peptides or calcium supplements.

Key findings

  • Whole-body BMD loss at 12 months was significantly attenuated in the calcium-collagen chelate group compared with control: −1.33% vs −3.75% in completers analysis (p=0.026) and −0.33% vs −2.17% in intention-to-treat analysis (p=0.035).
  • Serum sclerostin, an inhibitor of Wnt-mediated bone formation, was significantly lower in the calcium-collagen-chelate group versus control at 6 months (p<0.05).
  • Serum TRAP5b, a marker of osteoclast activity and bone resorption, was significantly lower in the intervention group versus control at 6 months (p<0.05).
  • The bone-specific alkaline phosphatase to TRAP5b ratio was significantly higher in the intervention group versus control at 6 months (p<0.05), indicating a more favourable formation-to-resorption balance.
  • Lumbar-spine and hip BMD differences did not reach statistical significance individually; the clearest reported BMD effect was for whole-body BMD.
  • No treatment-related adverse events were reported.

What this study can and cannot tell us

  • Substantial attrition by 12 months: only 22 of 39 randomized participants completed the 12-month visit (12 intervention, 10 control). The reported intention-to-treat analysis used last observation carried forward, which can bias long-term estimates when dropout is high.
  • Both arms received calcium plus vitamin D, so the trial does not isolate collagen against a true placebo. The comparison is calcium-collagen chelate plus vitamin D versus calcium plus vitamin D alone.
  • Only one chelate dose was tested; no dose-response relationship was established.
  • Commercial conflict-of-interest context is substantial: the trial was funded by AIDP Inc., co-author Jennifer Gu was affiliated with AIDP, and KoACT® is a proprietary commercial ingredient.
  • The cohort was limited to postmenopausal women in the United States, so generalizability to men and other populations is uncertain.
  • The study followed earlier work by the same group and product, which limits the amount of independent replication available for this formulation.
  • The statistically significant between-group signal was strongest for whole-body bone mineral density; lumbar-spine and hip measurements did not individually establish a clear fracture-relevant benefit.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology