Treatment of osteoporosis with a modified zeolite shows beneficial effects in an osteoporotic rat model and a human clinical trial

Pavelić, Sandra Kraljević; Micek, Vedran; Bobinac, Dragica; Bazdulj, Edo; Gianoncelli, Alessandra; Krpan, Dalibor; Žuvić, Marta; Eisenwagen, Sandra; Stambrook, Peter J.; Pavelić, Krešimir

doi:10.1177/1535370220968752

Cited by 12 publications

(20 citation statements)

References 46 publications

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“…The Pb values of the Verum groups, however, remained within the reference range in the first three years (TOP1-TOP3) and started to decrease in the fourth year of application (TOP4). The Pb levels were still in the reference range, and the PMA-zeolite-supplemented subjects had improved clinical parameters indicative of bone remodeling ( 15 ). Scientific evidence supports a high affinity of clinoptilolite for Pb ( 29 – 32 ), and as evidenced in the herein presented studies, additional concentrations were not detectable in the blood of subjects 1 h after uptake of PMA-zeolite.…”

Section: Discussionmentioning

confidence: 99%

“…The clinical results of the first year of the TOP study (TOP1) are published in Kraljević Pavelić et al ( 15 ). Herein, we report on the concentrations of minerals and contaminants in the blood of patients enrolled within this randomized, placebo-controlled, double-blinded study (NCT03901989) aimed to measure the long-term effects of PMA-zeolite on the bones of patients with osteoporosis who were supplemented with PMA-zeolite for a period up to 3 or 4 years (36 or 48 months, respectively, TOP1—first year of TOP study, TOP2—second year of the TOP study, TOP3—third year of the TOP study, and TOP4—fourth year of the TOP study).…”

Section: Methodsmentioning

confidence: 99%

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Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients

et al. 2022

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The natural clinoptilolite material is an inorganic crystal mineral called zeolite. It has been extensively studied and used in industrial applications and veterinary and human medicine due to positive effects on health. Limited data is available in the scientific literature about its effects on the levels of physiologically relevant minerals in the human organism. Accordingly, we performed a comprehensive and controlled monitoring of the relevant mineral and contaminants levels in human subjects supplemented with a certified clinoptilolite material within three clinical trials with different supplementation regimens. Effects of a registered and certified clinoptilolite material PMA-zeolite on selected mineral and metal levels were determined by standard biochemical methods and inductively coupled plasma mass spectrometry (ICP-MS) in the blood of subjects enrolled in three clinical trials: short-term (28 days, Mineral Metabolism and selected Blood Parameters study MMBP), medium-term (12 weeks, Morbus Crohn study), and long-term (4 years, Osteoporosis TOP study) supplementation. Lower concentrations were observed for copper (Cu) in patients with osteoporosis, which normalized again in the long-term supplementation trial, whereas sodium (Na) and calcium (Ca) levels diminished below the reference values in patients with osteoporosis. In the short- and long-term supplementation trials, increased levels of lead (Pb) were observed in PMA-zeolite-supplemented subjects, which decreased in the continued long-term supplementation trial. Increased levels of aluminum (Al) or Pb attributable to eventual leakage from the material into the bloodstream were not detected 1 h after intake in the short-term supplementation trial. Nickel (Ni) and Al were statistically significantly decreased upon long-term 4-year supplementation within the long-term supplementation trial, and arsenic (As) was statistically significantly decreased upon 12-weeks supplementation in the medium-term trial. Alterations in the measured levels for Na and Ca, as well as for Pb, in the long-term trial are probably attributable to the bone remodeling process. Checking the balance of the minerals Cu, Ca, and Na after 1 year of supplementation might be prescribed for PMA-supplemented patients with osteoporosis.Clinical Trial Registration[https://clinicaltrials.gov], identifiers [NCT03901989, NCT05178719, NCT04370535, NCT04607018].

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients

et al. 2022

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“…The bone strength depends mostly on the quality of collagen (osteoid) which gives a flexibility and microarchitecture, that cannot be measured directly in vivo ( 14 ). In our previous study by using the osteopenia rat model over a 16-week PMA-zeolite treatment, PMA-zeolite supplementation showed significant improvements in bone density markers and bone architecture and morphometric characteristics ( 10 ). These data were used as a rationale for the herein presented clinical study on human subjects diagnosed with osteoporosis.…”

Section: Discussionmentioning

confidence: 99%

“…Previous data from the preclinical and first year of the TOP study were previously published in Kraljević Pavelić et al ( 10 ). Herein, we present the summarized data of the whole randomized, placebo-controlled and double blinded TOP study (First year of the study: ClinicalTrials.gov Identifier: NCT03901989, https://clinicaltrials.gov/ct2/show/NCT03901989?term=zeolite&draw=2&rank=5 ; Treatment of Osteoporosis - second to fifth year (Pear Control): ClinicalTrials.gov Identifier: NCT05178719, https://clinicaltrials.gov/ct2/show/NCT05178719?term=zeolite&draw=2&rank=6 ).…”

Section: Methodsmentioning

confidence: 99%

Clinical Parameters in Osteoporosis Patients Supplemented With PMA-Zeolite at the End of 5-Year Double-Blinded Clinical Trial

et al. 2022

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Osteoporosis is among the most common pathologies. Associated complications in osteoporotic patients, in particular hip fractures and vertebral fractures, cause disabilities and significant quality of life deterioration. Standard treatment of osteoporosis, based on pharmacotherapy does still not yield adequate results, and the problem of osteoporosis remains incompletely solved. Additionally, adverse drug events and fractures after long-termed pharmacotherapy pose additional challenges within designing a proper therapy regimen. Improved clinical approach and new synergistic treatment modalities are consequently still needed. The rationale of the presented study was accordingly, to expand our preclinical animal study on human patients with osteoporosis, based on positive effects on bones observed in animals with osteopenia treated with PMA-zeolite. We specifically monitored effects of PMA-zeolite on the bone quality parameters, fracture risk and quality of life in a cohort of initially recruited 100 osteoporosis patients during a follow-up period of 5 years within a randomized, placebo-controlled and double blinded clinical study (TOP study). Obtained results provide evidence on the PMA-zeolite positive effects on the bone strength of osteoporotic patients as the risk of fractures was significantly decreased in PMA-zeolite-treated patients with respect to time before entering the study (p = 0.002). Statistical evidence point also to positive bone changes in the 5-years TOP study course as evidenced through osteocalcin and beta-cross laps values showing a prevalence of the bone-formation process (p < 0.05). BMD values were not significantly affected after the 5-years follow-up in PMA-zeolite-treated patients in comparison with the Placebo group. Results support the initial expectations based on our previously published preclinical studies on clinoptilolite product PMA-zeolite in animals that could be a new therapeutic option in osteoporosis patients.

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“…TwinMic capabilities have attracted the interest of scientists from different research fields, from the material sciences [18], especially from the energy field [19][20][21][22], to environmental sciences [23][24][25][26][27][28][29][30][31], the life sciences [32][33][34][35][36][37][38][39][40][41][42][43][44][45][46], and cultural heritage [47].…”

Section: Introductionmentioning

confidence: 99%

Soft X-ray Microscopy Techniques for Medical and Biological Imaging at TwinMic—Elettra

et al. 2021

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Progress in nanotechnology calls for material probing techniques of high sensitivity and resolution. Such techniques are also used for high-impact studies of nanoscale materials in medicine and biology. Soft X-ray microscopy has been successfully used for investigating complex biological processes occurring at micrometric and sub-micrometric length scales and is one of the most powerful tools in medicine and the life sciences. Here, we present the capabilities of the TwinMic soft X-ray microscopy end-station at the Elettra synchrotron in the context of medical and biological imaging, while we also describe novel uses and developments.

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Treatment of osteoporosis with a modified zeolite shows beneficial effects in an osteoporotic rat model and a human clinical trial

Cited by 12 publications

References 46 publications

Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients

Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients

Clinical Parameters in Osteoporosis Patients Supplemented With PMA-Zeolite at the End of 5-Year Double-Blinded Clinical Trial

Soft X-ray Microscopy Techniques for Medical and Biological Imaging at TwinMic—Elettra

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