Treatment of Osteoporosis - TOP 2-5 Clinical Studies (Pear Control)

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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Extension of the TOP 1-study (NCT03901989): Treatment of Osteoporosis by Panaceo, Pear Control Study Assessed Effect on Bone Mineral Density and Bone Turnover of Panaceo Compared to Placebo in Osteoporotic Patients

Conditions
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Osteoporosis

Intervention / Treatment
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* Device: PMA-zeolite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 100 subjects with osteoporosis Among those, as a subgroup, 20 subjects with diabetes type 2 and osteoporosis; The osteoporosis- was diagnosed by standard DXA measurement (BMD T-score: - 2.5 or below ) Exclusion Criteria: chronic renal failure, secondary osteoporosis

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PMA-zeolite<br>All subjects receive the substance 3 times per day in a measuring spoon as powder | Device: PMA-zeolite<br>* given for a total period of 4 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 0-12 months for a total period of 4 years |