Status:
TERMINATED
Effect of Vitamin K Supplementation on Circulating Levels of Osteocalcin on the Bone Metabolism and Aging
Lead Sponsor:
University of Milano Bicocca
Conditions:
Bone Metabolism Disorder
Aging Disorder
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
This is an interventional study on nutraceuticals. It is a randomized controlled, open-label, prospective, single-center study that involves the enrollment of 82 patients with osteoporosis and 41 subj...
Detailed Description
Background: OC, also known as bone-Gla-protein (BGP), is the main non-collagen protein of the extracellular matrix in mineralized tissues. It is synthesized by osteoblasts, odontoblasts, and hypertro...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Inclusion criteria for the group "Patients with osteoporosis":
- Age ≥ 65 years
- Serum levels of 25OHD\> 30 ng / ml (as per clinical practice)
- Adequate calcium intake (assessed by questionnaire)
- Diagnosis of severe primary osteoporosis
- Criteria for the prescription and reimbursement of treatment with Teriparatide 20 microg / day subcutaneous according to the Italian Agency of Pharma (AIFA) 79
- Patient suitable for treatment with MK-7
- Informed consent freely acquired before the person was enrolled
- Inclusion criteria for the group "subjects without osteoporosis":
- Age ≥ 65 years
- Serum levels of 25OHD\> 30 ng / ml (as per clinical practice)
- Adequate calcium intake (assessed by questionnaire).
- Informed consent freely acquired before the person was enrolled
- Exclusion Criteria:
- Exclusion criteria for the group of "Patients with osteoporosis":
- causes of secondary osteoporosis: current glucocorticoid therapy, active and uncontrolled rheumatic diseases, endogenous hypercortisolism, uncontrolled hyperthyroidism or hypothyroidism (except known hypothyroidism well compensated with L-thyroxine), chronic renal failure (IRC) with glomerular filtration rate (GFR) \<30 ml / min, multiple myeloma, liver failure (chronic liver disease of CHILD class B and C), heart failure (New York Heart Association, also said NHYA) NHYA\> 2, active neoplasms, type 1 and type 2 diabetes mellitus
- ongoing therapies: glucocorticoids, antiepileptics, aromatase inhibitors and similar gonadotropin-releasing hormone (GnRH, contraindicated for teriparatide).
- Exclusion criteria for the group "subjects without osteoporosis":
- ongoing therapies: glucocorticoids, antiepileptics, diphosphonates, teriparatide, denosumab, statins, oral or injective hypoglycemic agents, aromatase inhibitors, similar GnRH or other oncological therapies
- diagnosis of osteoporosis (according to World Health Organization, WHO) T-score \<-2.5 standard deviation (SD), at any site evaluated with ''Dual-Energy X-ray Absorptiometry'' (DXA)
- diagnosis of sarcopenia (according to ''Appendicular Skeletal Muscle Mass'', ASMMI) ASMMI \<7.59 kg / m2 for males and 5.47 kg / m2 for females evaluated with DXA
- diagnosis of IRC with estimated GFR \<30 ml / minute, liver failure (chronic liver disease of CHILD class B and C), heart failure with NHYA\> 2 , active neoplasms, endocrinopathies (except known hypothyroidism well compensated with L-thyroxine ), type 1 and type 2 diabetes mellitus.
Exclusion
Key Trial Info
Start Date :
November 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04669782
Start Date
November 24 2020
End Date
July 4 2024
Last Update
July 29 2025
Active Locations (1)
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1
Istituto Ortopedico Galeazzi IRCCS
Milan, Italy