Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05178719
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2021-12-16
Brief Title:
Treatment of Osteoporosis - TOP 2-5 Clinical Studies Pear Control
Sponsor:
Polyclinic K-center
Organization:
Polyclinic K-center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None