Treatment of Osteoporosis - TOP 2-5 Clinical Studies (Pear Control)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      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: 
      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)
    

Intervention name(s): PMA-zeolite
Intervention type(s): Device
Intervention description(s): given for a total period of 4 years
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Treatment