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Specific Collagen Peptides Improve Bone Mineral Density and Bone Markers in Postmenopausal Women — A Randomized Controlled Study

Daniel König, Steffen Oesser, Stephan Scharla, Denise Zdzieblik, Albert Gollhofer
Nutrients 2018 10(1):97

Bibliography

PubMed
PMID 29337906
PubMed Central
PMC5793325
DOI
10.3390/nu10010097
Funding
Part of the study was financially supported by GELITA AG, Germany. The planning, organization of the study as well as data analyses was performed solely by the investigators.
Competing interests
The paper states that the authors declared no conflict of interest. That declaration should be interpreted alongside disclosed commercial ties: GELITA AG partly funded the study, the tested FORTIBONE® preparation is a GELITA product, Steffen Oesser was affiliated with the Collagen Research Institute and has disclosed collagen-peptide patent interests elsewhere in the corpus, and Denise Zdzieblik later worked at the Collagen Research Institute.

Study snapshot

DesignSingle-centre, prospective, randomised, double-blind, placebo-controlled phase III trial
ModelPostmenopausal women (amenorrhoea ≥1 year) with age-related reduced bone mineral density (DXA T-score ≤ -1 at lumbar spine or femoral neck), no medical osteoporosis treatment in prior year
Samplen=131 randomised (66 SCP, 65 placebo); n=102 completed; all analysed via intention-to-treat
Intervention5 g/day Fortibone specific bioactive collagen peptides (mean MW ~5 kDa; GELITA AG) versus 5 g/day maltodextrin placebo, dissolved in water before breakfast. Both groups encouraged (not prescribed) to take calcium (~0.5–0.8 g/day) and vitamin D (400–800 IU/day).
Duration12 months, with interim examinations at 3 and 6 months
EndpointsPrimary: change in bone mineral density (BMD, T-score) at lumbar spine (L1–L4) and femoral neck by DXA; Secondary: plasma amino-terminal propeptide of type I collagen (P1NP) as bone formation marker; Plasma C-telopeptide of type I collagen (CTX-1) as bone resorption marker; Blood safety chemistry; adverse events

What the study showed, in plain terms

Researchers randomized 131 postmenopausal women with reduced bone density to 5 g/day of the specific FORTIBONE® collagen-peptide preparation or maltodextrin placebo for 12 months. Bone mineral density at the lumbar spine and femoral neck was measured by DXA, with P1NP and CTX-1 used as bone-turnover markers.

The collagen group showed statistically significant between-group differences in DXA bone-density outcomes at the spine and femoral neck, alongside changes in bone-turnover markers. No serious adverse events were reported.

This is placebo-controlled DXA evidence for one specific 5 g/day preparation over 12 months, not proof of a collagen class effect. The trial was partly manufacturer-funded, baseline spine BMD differed between groups, calcium and vitamin D intake were encouraged but not standardized, and independent replication is limited. Bone-density change does not establish fracture prevention.

Key findings

  • Lumbar-spine BMD T-score changed by +0.10 ± 0.26 in the collagen group versus −0.03 ± 0.18 with placebo; the adjusted between-group difference was significant (p=0.030).
  • Femoral-neck BMD T-score changed by +0.09 ± 0.24 with collagen versus −0.01 ± 0.19 with placebo; the adjusted between-group difference was significant (p=0.003).
  • Reported absolute BMD increased in the collagen group and declined in placebo, but baseline imbalance and the single proprietary preparation limit generalisation.
  • P1NP increased significantly within the collagen group, while CTX-1 increased within placebo. These biomarkers do not by themselves establish the mechanism or fracture prevention.
  • Blood-pressure changes were observed but were not a prespecified cardiovascular efficacy finding and should not be used to support a blood-pressure claim.
  • No serious adverse events were reported and measured safety laboratory parameters remained within normal ranges.

What this study can and cannot tell us

  • Baseline imbalance: the SCP group had significantly lower spine BMD at randomisation than placebo (p=0.005). ANCOVA was used to adjust, but any baseline imbalance in a randomised trial is a concern and can suggest randomisation failure.
  • 29 of 131 women dropped out (~22%). Intention-to-treat analysis mitigates this, but a drop-out rate this high in a 12-month trial can bias results if drop-outs differ systematically between arms.
  • Calcium and vitamin D intake was encouraged but not standardised or controlled — dietary records showed both groups had vitamin D intake below the recommended 20 μg/day. Uncontrolled variation in cofactor intake could influence BMD outcomes.
  • Blood pressure reduction observed in the SCP group is unexplained by the trial's design or biomarkers. It could be a genuine effect, chance, or an artefact — but it should not be extrapolated to a cardiovascular claim without dedicated studies.
  • Single-centre, single-sex (postmenopausal women), single-ethnicity German cohort. Generalisability to men, other ethnicities, or younger women is unproven.
  • Findings apply specifically to Fortibone (~5 kDa MW). Other collagen preparations may not produce equivalent results.
  • Industry funding and direct commercial ties of multiple authors to the manufacturer of the tested product. Independent replication by non-industry-affiliated groups has not yet been published at this scale and duration.
  • P1NP and CTX-1 blood biomarkers were measured by ELISA rather than automated immunoassay, which is not the current reference standard for bone turnover markers.

Related papers in the corpus

Tier 3
Specific Bioactive Collagen Peptides in Osteopenia and Osteoporosis: Long-Term Observation in Postmenopausal Women
Denise Zdzieblik et al. · Journal of Bone Metabolism · 2021

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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