Osteoporosis
Conditions
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.
Interventions
DEVICEzeolite
given for a period of 12 months
DEVICEcellulose
given for a period of 12 months
Sponsors
University of Rijeka
Polyclinic K-center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of BMD (Bone mineral density) | 0-6-12 months | BMD measurements are used to see how well osteoporosis treatments are working |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cange of Bone remodelling marker Osteocalcin | 0-6-12 months | Osteocalcin- parameter of the bone formation rate |
| Cange of Bone remodelling marker Betacross laps | 0-6-12 months | Betacross laps - parameter of the bone degradation rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fractures and fallings | 12 months | Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported |
| Intensity of the musculoskeletal pain measured by VAS | 0-12 months | the scale based on patient's subjective evaluation at the beginning and at the end of the study. |
| Subjective evaluation of the overall health status and 6. | 0-12 months | upon the end of the study in comparison to the beginning |
Outcome results
None listed