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Trial · Interventional

TerminatedNot applicableRegistry data

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

Short name OstMARK

NCTNCT04669782 (opens ClinicalTrials.gov in a new tab)Other idOstMARK
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
99 participants (actual)
Sponsor
University of Milano Bicocca · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Italy

Start
24 Nov 2020
Primary completion
4 Jul 2024
Completion
4 Jul 2024
First posted
17 Dec 2020
Last update posted
29 Jul 2025
Conditions
Bone Metabolism Disorder · Aging Disorder · Osteoporosis

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022202320242025
  1. N/A

    OstMARK

    NCT04669782

    24 Nov 2020 to 4 Jul 2024

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Vitamin K (MK7)Dietary supplement
  • TeriparatideDrug

Arms3

  • Experimental

    Patients with osteoporosis treated with teriparatide + Vitamin K

    Patients will have to take teriparatide (standard of care) + Vitamin K (MK7) at the dosage of 375 microg / day

  • Active comparator

    Patients with osteoporosis treated with teriparatide

    Patients will have to take teriparatide (standard of care)

  • No intervention

    Controls

    Subject without osteoporosis, no treatment will be administered.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Circulating levels of GluOC

    Time frame · 18 months

    Registry description

    Circulating levels of GluOC measured after 18 months of treatment with vitamin K

Secondary outcomes(1)

  1. Circulating levels of OC isoforms

    Time frame · 18 months

    Registry description

    Circulating levels of OC isoforms measured after 18 months of treatment with vitamin K

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2014

4 results

Comparison of the effect of 18-month daily teriparatide administration on patients with rheumatoid arthritis and postmenopausal osteoporosis patients.

Ebina et al. 2014Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 34

PMID 25082556DOI 10.1007/s00198-014-2819-xPUB-25082556

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

1 study on this page

Indexing hint: Clinical trial · 2007

Acute and chronic effect of teriparatide on glucose metabolism in women with established osteoporosis.

Anastasilakis et al. 2007Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Associationcited by 16

PMID 17318770DOI 10.1055/s-2007-967090PUB-17318770

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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