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| Name | Class |
|---|---|
| University of Rijeka | OTHER |
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Due to the fact that bone mineral density (BMD) is a not enough sensitive parameter for assessment of the bone quality and that the changes in BMD are gradually, extension of the clinical follow up is recommended. On that way the result will be more reliable.
Therefore the protocol "TOP 2-5" is the extension of TOP 1-study with a slight change of the study design. All subjects will be treated with Panaceo. It will be a "pear control", where the patient is control to himself, or herself (each patient from "placebo group (TOP1) can be compared after further years of threatment.
Additionally, extension of the follow up will provide an assessment of the fracture risk in a more reliable manner, which is considered as the most preferably outcome in majority clinical studies of osteoporosis treatment, because it is the most important requirement for the acceptance by the regulatory agencies (FDA, EMA).
Pear control study over 4 supplementation years. Study Population: The study population will consist of patients from a previous study (start: 100 and drop out rate) 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 receive PMA-zeolite .
Demonstration of efficacy of Panaceo in the treatment of osteoporosis by increasing bone mineral density and reduction of fracture risk.
Demonstration of efficacy of Panaceo in the treatment osteoporosis despite of the gender and cause.
Demonstration of efficacy of Panaceo in the patients who was on drug treatment (bisfosfonates or SERM) more than five years without significant improvement or those who are suspected on the bone turnover over-suppression.
Tolerability Safety (adverse events, vital signs, clinical chemistry)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMA-zeolite | Experimental | All subjects receive the substance 3 times per day in a measuring spoon as powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMA-zeolite | Device | given for a total period of 4 years |
|
| 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 for a total period of 4 years |
| Fractures and fallings | Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported | for a total period of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Bone remodelling marker Osteocalcin | Osteocalcin- parameter of the bone formation rate | 0-12 months for a total period of 4 years |
| Change of Bone remodelling marker Betacross laps | Betacross laps - parameter of the bone degradation rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-12 months for a total period of 4 years |
| Subjective evaluation of the overall health status |
Inclusion Criteria:
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. |
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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 started in 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. In the rears 2-5 only receiving the study substance.
The study TOP 2 started with 81 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.
Subjects were monitored at the start of the study and at the end of each study year. The surrogate markers of bone status are measured as follows: BMD, changes in levels of osteocalcin and beta-crosslaps CTx assay.
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no masking
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| 0-12 months for a total period of 4 years |
upon the end of the study in comparison to the beginning
| 0-12 months for a total period of 4 years |
| D009750 |
| Nutritional and Metabolic Diseases |