TerminatedNot Applicable

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

Stopped: Logistics/management problems at the recruiting center

Italy99 participantsStarted 2020-11-24

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 inhibit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Circulating levels of GluOC

Timeframe: 18 months

Trial details

NCT IDNCT04669782

SponsorUniversity of Milano Bicocca

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-04

View on ClinicalTrials.gov More Bone Metabolism Disorder trials