Clinical trial NCT03901989: Treatment of Osteoporosis - TOP1 Clinical Study
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Polyclinic K-center
Sponsor class: OTHER
Collaborators: name: University of Rijeka
First posted: 2019-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of BMD (Bone mineral density)
timeFrame: 0-6-12 months
Secondary outcomes:
measure: Cange of Bone remodelling marker Osteocalcin
timeFrame: 0-6-12 months
measure: Cange of Bone remodelling marker Betacross laps
timeFrame: 0-6-12 months
Other outcomes:
measure: Fractures and fallings
timeFrame: 12 months
measure: Intensity of the musculoskeletal pain measured by VAS
timeFrame: 0-12 months
measure: Subjective evaluation of the overall health status and 6.
timeFrame: 0-12 months
Locations:
Study officials:
References:
citation: 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.
citation: 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.