Treatment of Osteoporosis - TOP1 Clinical Study (TOP1)

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Device: zeolite; Device: cellulose

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractures and fallings	Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported	12 months
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
Subjective evaluation of the overall health status and 6.	upon the end of the study in comparison to the beginning	0-12 months

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.
• Kraljevic Pavelic S, Micek V, Bobinac D, Bazdulj E, Gianoncelli A, Krpan D, Zuvic M, Eisenwagen S, Stambrook PJ, Pavelic K. Treatment of osteoporosis with a modified zeolite shows beneficial effects in an osteoporotic rat model and a human clinical trial. Exp Biol Med (Maywood). 2021 Mar;246(5):529-537. doi: 10.1177/1535370220968752. Epub 2020 Nov 12. Erratum In: Exp Biol Med (Maywood). 2021 Mar 17;:15353702211004087.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2015
• Primary Completion (Actual): March 20, 2017
• Study Completion (Actual): March 20, 2017

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

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 001-2013

Drug and device information, study documents

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