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NCT Number: NCT05178719

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

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).

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PMA-zeolite

Device

given for a total period of 4 years

Primary outcomes

  1. Change of BMD (Bone mineral density)

    Time frame: 0-6-12 months for a total period of 4 years

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

  2. Fractures and fallings

    Time frame: 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

Secondary outcomes

  1. Change of Bone remodelling marker Osteocalcin

    Time frame: 0-12 months for a total period of 4 years

    Osteocalcin- parameter of the bone formation rate

  2. Change of Bone remodelling marker Betacross laps

    Time frame: 0-12 months for a total period of 4 years

    Betacross laps - parameter of the bone degradation rate

Other outcomes

  1. Intensity of the musculoskeletal pain measured by VAS

    Time frame: 0-12 months for a total period of 4 years

    the scale based on patient's subjective evaluation at the beginning and at the end of the study

  2. Subjective evaluation of the overall health status

    Time frame: 0-12 months for a total period of 4 years

    upon the end of the study in comparison to the beginning

Sponsors and collaborators

Lead sponsor

Polyclinic K-center

Other

Collaborators

  • University of Rijeka

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2022
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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