---
title: Treatment of Osteoporosis - TOP 2-5 Clinical Studies (Pear Control)
nct_id: NCT05178719
overall_status: COMPLETED
phase: NA
sponsor: Polyclinic K-center
study_type: INTERVENTIONAL
primary_condition: Osteoporosis
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05178719.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05178719"
ct_last_update_post_date: 2022-01-05
last_seen_at: "2026-05-12T07:17:15.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Treatment of Osteoporosis - TOP 2-5 Clinical Studies (Pear Control)

**Official 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

**NCT ID:** [NCT05178719](https://clinicaltrials.gov/study/NCT05178719)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 81
- **Lead Sponsor:** Polyclinic K-center
- **Collaborators:** University of Rijeka
- **Conditions:** Osteoporosis
- **Start Date:** 2016-03-16
- **Completion Date:** 2021-10-21
- **CT.gov Last Update:** 2022-01-05

## 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).

## Detailed Description

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)

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 100 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **PMA-zeolite** (EXPERIMENTAL) — All subjects receive the substance 3 times per day in a measuring spoon as powder

## Interventions

- **PMA-zeolite** (DEVICE) — given for a total period of 4 years

## Primary Outcomes

- **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
- **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

- **Change of Bone remodelling marker Osteocalcin** _(time frame: 0-12 months for a total period of 4 years)_
- **Change of Bone remodelling marker Betacross laps** _(time frame: 0-12 months for a total period of 4 years)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

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