Treatment of Osteoporosis - TOP1 Clinical Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Osteoporosis by Panaceo: Randomized, Double-blind, Controlled, 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: zeolite
* Device: cellulose


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: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: zeolite<br>50 subjects receive the substance 3 times per day as powder | Device: zeolite<br>* given for a period of 12 months<br>|
| Placebo Comparator: cellulose<br>50 subjects receive the substance 3 times per day as powder | Device: cellulose<br>* given for a period of 12 months<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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 0-6-12 months |