NCT04669782Terminated
Effect of Vitamin K Supplementation on Circulating Levels of Osteocalcin on the Bone Metabolism and Aging
Osteocalcin in Bone Metabolism and Aging: Effect of Vitamin K Supplementation on Circulating Levels of Osteocalcin, on Glucose and Energy Metabolism and on Muscle Mass and Function
Source: ClinicalTrials.gov · Last updated 29 Jul 2025
Reason given: Logistics/management problems at the recruiting center
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 24 Nov 2020
- Start date
- 24 Nov 2020
- Primary completion date
- 4 Jul 2024
- Lead sponsor
- University of Milano Bicocca
- Diseases
- Osteoporosis
- NCT number
- NCT04669782
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- 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
- 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.
Other
- 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
Who the study is looking for
- 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
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Ortopedico Galeazzi IRCCS | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.