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

What Was Tested

This registered not phased trial tested Teriparatide for osteoporosis and bone density.

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.

It had three arms (groups): Patients with osteoporosis treated with teriparatide + Vitamin K (experimental), Patients with osteoporosis treated with teriparatide (active comparator) and Controls (no intervention).

Patients will have to take teriparatide (standard of care).

Subject without osteoporosis, no treatment will be administered.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Background: OC, also known as bone-Gla-protein (BGP), is the main non-collagen protein of the extracellular matrix in mineralized tissues.

It is synthesized by osteoblasts, odontoblasts, and hypertrophic chondrocytes and, through its negative charges, binds calcium and regulates the formation of hydroxyapatite crystals.

In humans, circulating OC levels negatively correlate with fasting blood glucose and insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), body mass index (BMI), hyperlipidemia, and circulating concentrations of leptin.

There is various evidence regarding the usefulness of using the decarboxylated form of OC as a biomarker for monitoring the response to anti-osteoporotic treatments.

Who Took Part

The registry lists 99 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Patient suitable for treatment with MK-7.

The full record lists 11 inclusion and 6 exclusion criteria; among the exclusions: ongoing therapies: glucocorticoids, antiepileptics, aromatase inhibitors and similar gonadotropin-releasing hormone (gnrh, contraindicated for teriparatide); 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).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the osteoporosis and bone density participants stayed in one arm throughout.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2020-11-24 with completion listed for 2024-07-04.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Circulating levels of GluOC (time frame: 18 months).

It also tracked 1 secondary outcome, for example Circulating levels of OC isoforms.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Teriparatide in 99 people with osteoporosis and bone density.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, Osteoporosis and bone density research.