Treatment of Osteoporosis - TOP1 Clinical Study

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-14

Study Completion Date

2017-03-20

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.

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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zeolite

50 subjects receive the substance 3 times per day as powder

Group Type ACTIVE_COMPARATOR

zeolite

Intervention Type DEVICE

given for a period of 12 months

cellulose

50 subjects receive the substance 3 times per day as powder

Group Type PLACEBO_COMPARATOR

cellulose

Intervention Type DEVICE

given for a period of 12 months

Interventions

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zeolite

given for a period of 12 months

Intervention Type DEVICE

cellulose

given for a period of 12 months

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 )