Treatment of Osteoporosis - TOP1 Clinical Study

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Device: cellulose; Device: zeolite

• Registration Number: NCT03901989
• Lead Sponsor: Polyclinic K-center

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.

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 Timeline

• Study Start: 2015-01-14
• Primary Completion: 2017-03-20
• Study Completion: 2017-03-20
• Study First Submitted: 2019-03-08
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Study First Posted: 2019-04-03
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cellulose	cellulose	50 subjects receive the substance 3 times per day as powder
zeolite	zeolite	50 subjects receive the substance 3 times per day as powder

Primary Outcome Measures

Name	Time	Method
Change of BMD (Bone mineral density)	0-6-12 months	BMD measurements are used to see how well osteoporosis treatments are working

Secondary Outcome Measures

Name	Time	Method
Cange of Bone remodelling marker Osteocalcin	0-6-12 months	Osteocalcin- parameter of the bone formation rate
Cange of Bone remodelling marker Betacross laps	0-6-12 months	Betacross laps - parameter of the bone degradation rate