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Completed

NCT Number: NCT03901989

Treatment of Osteoporosis - TOP1 Clinical Study

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.

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

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

zeolite

Device

given for a period of 12 months

cellulose

Device

given for a period of 12 months

Primary outcomes

  1. Change of BMD (Bone mineral density)

    Time frame: 0-6-12 months

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

Secondary outcomes

  1. Cange of Bone remodelling marker Osteocalcin

    Time frame: 0-6-12 months

    Osteocalcin- parameter of the bone formation rate

  2. Cange of Bone remodelling marker Betacross laps

    Time frame: 0-6-12 months

    Betacross laps - parameter of the bone degradation rate

Other outcomes

  1. Fractures and fallings

    Time frame: 12 months

    Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported

  2. Intensity of the musculoskeletal pain measured by VAS

    Time frame: 0-12 months

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

  3. Subjective evaluation of the overall health status and 6.

    Time frame: 0-12 months

    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

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

Acronym: TOP1

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 3, 2019
Registry last updated
Apr 3, 2019

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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