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

NCT05178719 | Completed

• 1 other identifier: TOP 002-005-2016
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change of Bone remodelling marker Osteocalcin

  0-12 months for a total period of 4 years

• Change of Bone remodelling marker Betacross laps

  0-12 months for a total period of 4 years

Other Outcomes (2)

• Intensity of the musculoskeletal pain measured by VAS

  0-12 months for a total period of 4 years

• Subjective evaluation of the overall health status

  0-12 months for a total period of 4 years

Study Arms (1)

PMA-zeolite

EXPERIMENTAL

All subjects receive the substance 3 times per day in a measuring spoon as powder

Device: PMA-zeolite

Interventions

PMA-zeolite DEVICE

given for a total period of 4 years

PMA-zeolite

Eligibility Criteria

• Age: 40 Years - 100 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 (1)

• 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

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: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr.sc. Dalibor Krpan, prim.dr.med.

Model Details: The clinical study started in 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. In the rears 2-5 only receiving the study substance. The study TOP 2 started with 81 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. Subjects were monitored at the start of the study and at the end of each study year. The surrogate markers of bone status are measured as follows: BMD, changes in levels of osteocalcin and beta-crosslaps CTx assay.

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: March 16, 2016
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-12