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

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Device: PMA-zeolite

• Registration Number: NCT05178719
• Lead Sponsor: Polyclinic K-center

Brief 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)

Study Timeline

• Study Start: 2016-03-16
• Primary Completion: 2021-10-21
• Study Completion: 2021-10-21
• Status Verified: 2021-12
• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Last Update Submitted: 2021-12-16
• Study First Posted: 2022-01-05
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PMA-zeolite	PMA-zeolite	All subjects receive the substance 3 times per day in a measuring spoon as powder

Primary Outcome Measures

Name	Time	Method
Fractures and fallings	for a total period of 4 years	Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported
Change of BMD (Bone mineral density)	0-6-12 months for a total period of 4 years	BMD measurements are used to see how well osteoporosis treatments are working

Secondary Outcome Measures

Name	Time	Method
Change of Bone remodelling marker Osteocalcin	0-12 months for a total period of 4 years	Osteocalcin- parameter of the bone formation rate
Change of Bone remodelling marker Betacross laps	0-12 months for a total period of 4 years	Betacross laps - parameter of the bone degradation rate