OsteoporosisTOP1NCT03901989
Treatment of Osteoporosis - TOP1 Clinical Study
A study testing zeolite and cellulose in people with Osteoporosis, run by Polyclinic K-center.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- zeolite and cellulose
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2015to 20 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 )
Who cannot join
- chronic renal failure, secondary osteoporosis
About this 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
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- zeolite, cellulose
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zeoliteDevice
given for a period of 12 months
celluloseDevice
given for a period of 12 months
| Study group | Role | What they receive |
|---|---|---|
| zeolite | Active comparator | 50 subjects receive the substance 3 times per day as powder Receives: Device: zeolite |
| cellulose | Placebo comparator | 50 subjects receive the substance 3 times per day as powder Receives: Device: cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of BMD (Bone mineral density)
BMD measurements are used to see how well osteoporosis treatments are working
Measured: 0-6-12 months
Secondary outcomes (2)
Cange of Bone remodelling marker Osteocalcin
Osteocalcin- parameter of the bone formation rate
Measured: 0-6-12 months
Cange of Bone remodelling marker Betacross laps
Betacross laps - parameter of the bone degradation rate
Measured: 0-6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start14 Jan 2015
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyclinic K-center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Principal investigator, DALIBOR KRPAN, Polyclinic K-center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901989
- Sponsor's protocol ID
- TOP 001-2013
- Acronym
- TOP1
- Status last verified
- Apr 2019
- First submitted
- 8 Mar 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35712111Kraljevic 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.
PubMed 33183068
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03901989
- Acronym / sponsor ID
- TOP1 / TOP 001-2013
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Polyclinic K-centerUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- 14 Jan 2015 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| zeolite | Active comparator | Device: zeolite50 subjects receive the substance 3 times per day as powder |
| cellulose | Placebo comparator | Device: cellulose50 subjects receive the substance 3 times per day as powder |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 100 subjects with osteoporosis Among those, as a subgroup, 20 subjects with diabetes type 2 and osteoporosis
Key exclusion criteria (1 listed)
- chronic renal failure, secondary osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zeolitegiven for a period of 12 months | Device | zeolite |
| cellulosegiven for a period of 12 months | Device | cellulose |
Primary outcome
Change of BMD (Bone mineral density)
Time frame: 0-6-12 months
BMD measurements are used to see how well osteoporosis treatments are working
2 secondary outcomes
Cange of Bone remodelling marker Osteocalcin
Time frame: 0-6-12 months
Cange of Bone remodelling marker Betacross laps
Time frame: 0-6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Derived from this study: PubMed 35712111Kraljevic 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.
- Derived from this study: PubMed 33183068Kraljevic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing zeolite and cellulose in people with Osteoporosis, run by Polyclinic K-center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of BMD (Bone mineral density) (time frame: 0-6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901989, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.