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| Name | Class |
|---|---|
| University of Rijeka | OTHER |
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This study investigates the effect of zeolite on bone mineral metabolism. The clinical parameters include bone mineral density, bone remodelling markers, fractures and fallings, the subjective evaluation of the overall health status and intensity of the musculoskeletal pain measured by VAS.
Randomized, placebo-controlled, double-blind study. The Study lasts 12 months. Study Population: The study population will consist of 100 patients with osteoporosis defined according BMD (bone mineral density) criteria: T score -2, 5 on the femoral neck, and, or T -2, 5 on L1-L5, who has not been treated before, or in whom privies treatment did not been successful, despite a gender or age. Subjects will be randomized in each cohort to receive PMA-zeolite (Panaceo) or placebo (1:1). All of them will receive Vit D3 800 j daily.
The double blind design can be reached by a "third party blinding" where a qualified person, not being involved in the assessment of the study, will administer the study treatment.
Follow up DXA, Ca, P, ALP, Osteocalcin, Cross laps, Creatinin will be done to each subject before the treatment, 6 months later and after 12 months. IVA (vertebral deformity assessment) will be performed before the treatment and after 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zeolite | Active Comparator | 50 subjects receive the substance 3 times per day as powder |
|
| cellulose | Placebo Comparator | 50 subjects receive the substance 3 times per day as powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zeolite | Device | given for a period of 12 months |
| |
| cellulose |
| Measure | Description | Time Frame |
|---|---|---|
| Change of BMD (Bone mineral density) | BMD measurements are used to see how well osteoporosis treatments are working | 0-6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cange of Bone remodelling marker Osteocalcin | Osteocalcin- parameter of the bone formation rate | 0-6-12 months |
| Cange of Bone remodelling marker Betacross laps | Betacross laps - parameter of the bone degradation rate |
| Measure | Description | Time Frame |
|---|---|---|
| Fractures and fallings | Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported | 12 months |
| Intensity of the musculoskeletal pain measured by VAS | the scale based on patient's subjective evaluation at the beginning and at the end of the study. |
Inclusion Criteria:
100 subjects with osteoporosis Among those, as a subgroup, 20 subjects with diabetes type 2 and osteoporosis
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35712111 | Derived | Kraljevic Pavelic S, Saftic Martinovic L, Simovic Medica J, Zuvic M, Perdija Z, Krpan D, Eisenwagen S, Orct T, Pavelic K. Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients. Front Med (Lausanne). 2022 May 27;9:851782. doi: 10.3389/fmed.2022.851782. eCollection 2022. | |
| 33183068 |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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The clinical study is a randomized, double-blinded, controlled study aimed to assess the effect of zeolite-intervention in osteoporotic patients on the bone mineral density and bone turnover in comparison to osteoporotic patients control group that received the placebo over a period of for 12 months. The study population will consist of 100 patients with osteoporosis defined according BMD criteria: T score -2, 5 on the femoral neck, and, or T -2, 5 on L1-L5, who have not been treated before, or in whom privies treatment did not been successful, despite a gender or age. The Panaceo and Placebo groups will be divided into 50 and 50 patients.
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| Device |
given for a period of 12 months |
|
| 0-6-12 months |
| 0-12 months |
| Subjective evaluation of the overall health status and 6. | upon the end of the study in comparison to the beginning | 0-12 months |
| Kraljevic Pavelic S, Micek V, Bobinac D, Bazdulj E, Gianoncelli A, Krpan D, Zuvic M, Eisenwagen S, Stambrook PJ, Pavelic K. Treatment of osteoporosis with a modified zeolite shows beneficial effects in an osteoporotic rat model and a human clinical trial. Exp Biol Med (Maywood). 2021 Mar;246(5):529-537. doi: 10.1177/1535370220968752. Epub 2020 Nov 12. |
| D009750 |
| Nutritional and Metabolic Diseases |