Overview

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.