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

Extension of the TOP 1-study (NCT03901989): Treatment of Osteoporosis by Panaceo, Pear Control Study Assessed Effect on Bone Mineral Density and Bone Turnover of Panaceo Compared to Placebo in Osteoporotic Patients

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).

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Device: PMA-zeolite

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PMA-zeolite; All subjects receive the substance 3 times per day in a measuring spoon as powder	Device: PMA-zeolite; given for a total period of 4 years

What is the study measuring?

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 for a total period of 4 years
Fractures and fallings	Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported	for a total period of 4 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of the musculoskeletal pain measured by VAS	the scale based on patient's subjective evaluation at the beginning and at the end of the study	0-12 months for a total period of 4 years
Subjective evaluation of the overall health status	upon the end of the study in comparison to the beginning	0-12 months for a total period of 4 years

Collaborators and Investigators

• Sponsor: Polyclinic K-center
• Collaborators: University of Rijeka

Publications and helpful links

General Publications

• Kraljevic Pavelic S, Saftic Martinovic L, Simovic Medica J, Zuvic M, Perdija Z, Krpan D, Eisenwagen S, Orct T, Pavelic K. Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients. Front Med (Lausanne). 2022 May 27;9:851782. doi: 10.3389/fmed.2022.851782. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2016
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: TOP 002-005-2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No