Treatment of Osteoporosis - TOP1 Clinical Study

NCT03901989 | Completed

• 1 other identifier: TOP 001-2013
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Change of BMD (Bone mineral density)

  BMD measurements are used to see how well osteoporosis treatments are working

  0-6-12 months

Secondary Outcomes (2)

• Cange of Bone remodelling marker Osteocalcin

  0-6-12 months

• Cange of Bone remodelling marker Betacross laps

  0-6-12 months

Other Outcomes (3)

• Fractures and fallings

  12 months

• Intensity of the musculoskeletal pain measured by VAS

  0-12 months

• Subjective evaluation of the overall health status and 6.

  0-12 months

Study Arms (2)

zeolite

ACTIVE COMPARATOR

50 subjects receive the substance 3 times per day as powder

Device: zeolite

cellulose

PLACEBO COMPARATOR

50 subjects receive the substance 3 times per day as powder

Device: cellulose

Interventions

zeolite DEVICE

given for a period of 12 months

zeolite

cellulose DEVICE

given for a period of 12 months

cellulose

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• chronic renal failure, secondary osteoporosis

Sponsors & Collaborators

• Polyclinic K-center: lead
• University of Rijeka: collaborator

Related Publications (2)

• 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.

  PMID: 35712111 DERIVED

• 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.

  PMID: 33183068 DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr.sc. Dalibor Krpan, prim.dr.med.

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: April 3, 2019
• Study Start: January 14, 2015
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: April 3, 2019

Record last verified: 2019-04