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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-16

Study Completion Date

2021-10-21

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).

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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)

Conditions

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Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no masking

Study Groups

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PMA-zeolite

All subjects receive the substance 3 times per day in a measuring spoon as powder

Group Type EXPERIMENTAL

PMA-zeolite

Intervention Type DEVICE

given for a total period of 4 years

Interventions

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PMA-zeolite

given for a total period of 4 years

Intervention Type DEVICE

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 )