Treatment of Osteoporosis - TOP 2-5 Clinical Studies (Pear Control)

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178719
• Other study ID #: TOP 002-005-2016
• Status: Completed
• Phase: N/A
• Start date: March 16, 2016
• Est. completion date: October 21, 2021

Study information

• Verified date: December 2021
• Source: Polyclinic K-center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 21, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Device:
• PMA-zeolite
given for a total period of 4 years

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Polyclinic K-center	University of Rijeka

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intensity of the musculoskeletal pain measured by VAS	the scale based on patient's subjective evaluation at the beginning and at the end of the study	0-12 months for a total period of 4 years
Other	Subjective evaluation of the overall health status	upon the end of the study in comparison to the beginning	0-12 months for a total period of 4 years
Primary	Change of BMD (Bone mineral density)	BMD measurements are used to see how well osteoporosis treatments are working	0-6-12 months for a total period of 4 years
Primary	Fractures and fallings	Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported	for a total period of 4 years
Secondary	Change of Bone remodelling marker Osteocalcin	Osteocalcin- parameter of the bone formation rate	0-12 months for a total period of 4 years
Secondary	Change of Bone remodelling marker Betacross laps	Betacross laps - parameter of the bone degradation rate	0-12 months for a total period of 4 years