Effect of Vitamin K Supplementation on Circulating Levels of Osteocalcin on the Bone Metabolism and Aging (OstMARK)
Bone Metabolism Disorder, Aging Disorder, Osteoporosis
About this trial
This is an interventional treatment trial for Bone Metabolism Disorder focused on measuring osteocalcin, vitamin k
Eligibility Criteria
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.
Sites / Locations
- Istituto Ortopedico Galeazzi IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Patients with osteoporosis treated with teriparatide + Vitamin K
Patients with osteoporosis treated with teriparatide
Controls
Patients will have to take teriparatide (standard of care) + Vitamin K (MK7) at the dosage of 375 microg / day
Patients will have to take teriparatide (standard of care)
Subject without osteoporosis, no treatment will be administered.