Effect of Vitamin K Supplementation on Circulating Levels of Osteocalcin on the Bone Metabolism and Aging

• Status: Active, not recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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 subjects without osteoporosis.

The hypothesis the decarboxylated form of Osteocalcin (OC), called GluOC, represents a clinically useful marker for monitoring the effects of supplementation with vitamin K in association with anabolic treatment with teriparatide will be analyzed not only on bone but also on skeletal muscle and energy metabolism in patients with severe osteoporosis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milano Bicocca
• Treatments: Teriparatide; Vitamin K

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.