Bone Metabolism DisorderOstMARKNCT04669782
Effect of Vitamin K Supplementation on Circulating Levels of Osteocalcin on the Bone Metabolism and Aging
A study testing Vitamin K (MK7) and Teriparatide in people with Bone Metabolism Disorder and Aging Disorder, run by University of Milano Bicocca at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bone Metabolism Disorder, Aging Disorder, Osteoporosis
- What is being tested?
- Vitamin K (MK7) and Teriparatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- 24 Nov 2020to 4 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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. Weight loss (resulting from diet and / or physical activity) improves metabolic profile and muscle strength and increases OC levels.
It's interesting to note that high plasma levels of vitamin K or dietary supplementation (MK-7, the natural derivative of vitamin K2), correlate with a reduction in the loss of bone mass and quality. In addition, short-term (1 week) and long-term (3 years) vitamin K supplementation improves insulin resistance in both young and old males and high vitamin K consumption is associated with reduced insulin resistance and reduced risk of developing type 2 mellitus diabetes.
Recently, it has been reported in mice that the combination of teriparatide (TPT) and vitamin K is more effective than ionotherapy in improving bone formation, bone density and strength, and in inhibiting bone resorption.
Given the putative relevance of the decarboxylated form of OC, GluOC, in the endocrine interaction between bone and organs responsible for the management of energy resources (e.g. endocrine pancreas, skeletal muscle and adipose tissue) whose function is deregulated in elderly subjects and in the syndrome of fragility, this study aims to define a role of supplementation with vitamin K in osteoporosis, another condition characterizing the frailty of the elderly, on the endocrine function of bone tissue and the consequent effects on energy metabolism.
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. In particular, the circulating levels of GluOC respond both to osteometabolic treatments (teriparatide) and to supplementation with vitamin K, in a more relevant way than to total osteocalcin.
Study design and treatment:
The study includes the following phases:
- enrollment of controls, after obtaining informed consent.
- enrollment of patients, after obtaining informed consent.
- randomization for the patient group
- prescription teriparatide +/- Vitamin K depending on the group to which it belongs
- re-evaluation of patients after 6, 12 and 18 months of treatment
The group of patients randomized to the teriparatide + Vitamin K / Menaquinone MK-7 arm will have to take MK-7 at a dose of 375 microg / day.
Randomization:
Patients with osteoporosis will be randomized 1: 1 to one of two treatment groups:
- Teriparatide + Vitamin K
- Teriparatide
The randomization list will be generated with SAS 9.4 software (SAS Institute Inc., Cary, USA) and foresees the presence of blocks.
Statistical Analysis:
The analysis of the covariance will be performed to evaluate the effect of treatment with and without vitamin K / MK-7 on the primary endpoint measured at 18 months, adjusting for its baseline value (α = 0.05, two-tailed test). The results will also be described in terms of means and 95% confidence intervals both of the absolute values of GluOC at 18 months and of its variations from baseline. This approach will also be followed for the evaluation of the effect of the intake of vitamin K / MK-7 on the secondary endpoints defined by the OC isoforms.
The association between GluOC and Gla-type Osteocalcin (GlaOC) levels at 18 months (and changes from baseline) with respect to the markers of energy, bone and muscle metabolism measured at 18 months will also be explored through a linear regression model.
- Conditions
- Bone Metabolism Disorder, Aging Disorder, Osteoporosis
- Being tested
- Vitamin K (MK7), Teriparatide
- Keywords
- osteocalcin, vitamin k
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K (MK7)Dietary supplement
MK-7 will be administered at a dose of 375 microg / day
TeriparatideDrug
Teriparatide will be administered as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Patients with osteoporosis treated with teriparatide + Vitamin K | Experimental | Patients will have to take teriparatide (standard of care) + Vitamin K (MK7) at the dosage of 375 microg / day Receives: Dietary Supplement: Vitamin K (MK7); Drug: Teriparatide |
| Patients with osteoporosis treated with teriparatide | Active comparator | Patients will have to take teriparatide (standard of care) Receives: Drug: Teriparatide |
| Controls | No intervention | Subject without osteoporosis, no treatment will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating levels of GluOC
Circulating levels of GluOC measured after 18 months of treatment with vitamin K
Measured: 18 months
Secondary outcomes (1)
Circulating levels of OC isoforms
Circulating levels of OC isoforms measured after 18 months of treatment with vitamin K
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start24 Nov 2020
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Why it stopped: Logistics/management problems at the recruiting center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bone Metabolism DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669782
- Sponsor's protocol ID
- OstMARK
- Acronym
- OstMARK
- Status last verified
- Jul 2025
- First submitted
- 24 Nov 2020
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Airoldi C, Giovannardi S, La Ferla B, Jimenez-Barbero J, Nicotra F. Saturation transfer difference NMR experiments of membrane proteins in living cells under HR-MAS conditions: the interaction of the SGLT1 co-transporter with its ligands. Chemistry. 2011 Nov 25;17(48):13395-9. doi: 10.1002/chem.201102181. Epub 2011 Oct 27. No abstract available.
PubMed 22031470Anastasilakis A, Goulis DG, Koukoulis G, Kita M, Slavakis A, Avramidis A. Acute and chronic effect of teriparatide on glucose metabolism in women with established osteoporosis. Exp Clin Endocrinol Diabetes. 2007 Feb;115(2):108-11. doi: 10.1055/s-2007-967090.
PubMed 17318770Ebina K, Hashimoto J, Shi K, Kashii M, Hirao M, Yoshikawa H. Comparison of the effect of 18-month daily teriparatide administration on patients with rheumatoid arthritis and postmenopausal osteoporosis patients. Osteoporos Int. 2014 Dec;25(12):2755-65. doi: 10.1007/s00198-014-2819-x. Epub 2014 Aug 1.
PubMed 25082556Ferron M, McKee MD, Levine RL, Ducy P, Karsenty G. Intermittent injections of osteocalcin improve glucose metabolism and prevent type 2 diabetes in mice. Bone. 2012 Feb;50(2):568-75. doi: 10.1016/j.bone.2011.04.017. Epub 2011 Apr 29.
PubMed 21550430Grasso D, Corsetti R, Lanteri P, Di Bernardo C, Colombini A, Graziani R, Banfi G, Lombardi G. Bone-muscle unit activity, salivary steroid hormones profile, and physical effort over a 3-week stage race. Scand J Med Sci Sports. 2015 Feb;25(1):70-80. doi: 10.1111/sms.12147. Epub 2013 Oct 31.
PubMed 24433517Gundberg CM, Lian JB, Booth SL. Vitamin K-dependent carboxylation of osteocalcin: friend or foe? Adv Nutr. 2012 Mar 1;3(2):149-57. doi: 10.3945/an.112.001834.
PubMed 22516722Knapen MHJ, Jardon KM, Vermeer C. Vitamin K-induced effects on body fat and weight: results from a 3-year vitamin K2 intervention study. Eur J Clin Nutr. 2018 Jan;72(1):136-141. doi: 10.1038/ejcn.2017.146. Epub 2017 Sep 27.
PubMed 28952607
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04669782
- Acronym / sponsor ID
- OstMARK / OstMARK
- Conditions
- Bone Metabolism Disorder, Aging Disorder, Osteoporosis
- Keywords
- osteocalcin, vitamin k
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistics/management problems at the recruiting center
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Weight loss (resulting from diet and / or physical activity) improves metabolic profile and muscle strength and increases OC levels.
It's interesting to note that high plasma levels of vitamin K or dietary supplementation (MK-7, the natural derivative of vitamin K2), correlate with a reduction in the loss of bone mass and quality. In addition, short-term (1 week) and long-term (3 years) vitamin K supplementation improves insulin resistance in both young and old males and high vitamin K consumption is associated with reduced insulin resistance and reduced risk of developing type 2 mellitus diabetes.
Recently, it has been reported in mice that the combination of teriparatide (TPT) and vitamin K is more effective than ionotherapy in improving bone formation, bone density and strength, and in inhibiting bone resorption.
Given the putative relevance of the decarboxylated form of OC, GluOC, in the endocrine interaction between bone and organs responsible for the management of energy resources (e.g. endocrine pancreas, skeletal muscle and adipose tissue) whose function is deregulated in elderly subjects and in the syndrome of fragility, this study aims to define a role of supplementation with vitamin K in osteoporosis, another condition characterizing the frailty of the elderly, on the endocrine function of bone tissue and the consequent effects on energy metabolism.
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. In particular, the circulating levels of GluOC respond both to osteometabolic treatments (teriparatide) and to supplementation with vitamin K, in a more relevant way than to total osteocalcin.
Study design and treatment:
The study includes the following phases:
- enrollment of controls, after obtaining informed consent.
- enrollment of patients, after obtaining informed consent.
- randomization for the patient group
- prescription teriparatide +/- Vitamin K depending on the group to which it belongs
- re-evaluation of patients after 6, 12 and 18 months of treatment
The group of patients randomized to the teriparatide + Vitamin K / Menaquinone MK-7 arm will have to take MK-7 at a dose of 375 microg / day.
Randomization:
Patients with osteoporosis will be randomized 1: 1 to one of two treatment groups:
- Teriparatide + Vitamin K
- Teriparatide
The randomization list will be generated with SAS 9.4 software (SAS Institute Inc., Cary, USA) and foresees the presence of blocks.
Statistical Analysis:
The analysis of the covariance will be performed to evaluate the effect of treatment with and without vitamin K / MK-7 on the primary endpoint measured at 18 months, adjusting for its baseline value (α = 0.05, two-tailed test). The results will also be described in terms of means and 95% confidence intervals both of the absolute values of GluOC at 18 months and of its variations from baseline. This approach will also be followed for the evaluation of the effect of the intake of vitamin K / MK-7 on the secondary endpoints defined by the OC isoforms.
The association between GluOC and Gla-type Osteocalcin (GlaOC) levels at 18 months (and changes from baseline) with respect to the markers of energy, bone and muscle metabolism measured at 18 months will also be explored through a linear regression model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with osteoporosis treated with teriparatide + Vitamin K | Experimental | Dietary Supplement: Vitamin K (MK7), Drug: TeriparatidePatients will have to take teriparatide (standard of care) + Vitamin K (MK7) at the dosage of 375 microg / day |
| Patients with osteoporosis treated with teriparatide | Active comparator | Drug: TeriparatidePatients will have to take teriparatide (standard of care) |
| Controls | No intervention | –Subject without osteoporosis, no treatment will be administered. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K (MK7)MK-7 will be administered at a dose of 375 microg / day | Dietary supplement | Patients with osteoporosis treated with teriparatide + Vitamin K |
| TeriparatideTeriparatide will be administered as standard of care | Drug | Patients with osteoporosis treated with teriparatide, Patients with osteoporosis treated with teriparatide + Vitamin K |
Primary outcome
Circulating levels of GluOC
Time frame: 18 months
Circulating levels of GluOC measured after 18 months of treatment with vitamin K
1 secondary outcome
Circulating levels of OC isoforms
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Logistics/management problems at the recruiting center). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 22031470Airoldi C, Giovannardi S, La Ferla B, Jimenez-Barbero J, Nicotra F. Saturation transfer difference NMR experiments of membrane proteins in living cells under HR-MAS conditions: the interaction of the SGLT1 co-transporter with its ligands. Chemistry. 2011 Nov 25;17(48):13395-9. doi: 10.1002/chem.201102181. Epub 2011 Oct 27. No abstract available.
- Background: PubMed 17318770Anastasilakis A, Goulis DG, Koukoulis G, Kita M, Slavakis A, Avramidis A. Acute and chronic effect of teriparatide on glucose metabolism in women with established osteoporosis. Exp Clin Endocrinol Diabetes. 2007 Feb;115(2):108-11. doi: 10.1055/s-2007-967090.
- Background: PubMed 25082556Ebina K, Hashimoto J, Shi K, Kashii M, Hirao M, Yoshikawa H. Comparison of the effect of 18-month daily teriparatide administration on patients with rheumatoid arthritis and postmenopausal osteoporosis patients. Osteoporos Int. 2014 Dec;25(12):2755-65. doi: 10.1007/s00198-014-2819-x. Epub 2014 Aug 1.
- Background: PubMed 21550430Ferron M, McKee MD, Levine RL, Ducy P, Karsenty G. Intermittent injections of osteocalcin improve glucose metabolism and prevent type 2 diabetes in mice. Bone. 2012 Feb;50(2):568-75. doi: 10.1016/j.bone.2011.04.017. Epub 2011 Apr 29.
- Background: PubMed 24433517Grasso D, Corsetti R, Lanteri P, Di Bernardo C, Colombini A, Graziani R, Banfi G, Lombardi G. Bone-muscle unit activity, salivary steroid hormones profile, and physical effort over a 3-week stage race. Scand J Med Sci Sports. 2015 Feb;25(1):70-80. doi: 10.1111/sms.12147. Epub 2013 Oct 31.
- Background: PubMed 22516722Gundberg CM, Lian JB, Booth SL. Vitamin K-dependent carboxylation of osteocalcin: friend or foe? Adv Nutr. 2012 Mar 1;3(2):149-57. doi: 10.3945/an.112.001834.
- Background: PubMed 28952607Knapen MHJ, Jardon KM, Vermeer C. Vitamin K-induced effects on body fat and weight: results from a 3-year vitamin K2 intervention study. Eur J Clin Nutr. 2018 Jan;72(1):136-141. doi: 10.1038/ejcn.2017.146. Epub 2017 Sep 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K (MK7) and Teriparatide in people with Bone Metabolism Disorder and Aging Disorder, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Logistics/management problems at the recruiting center). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating levels of GluOC (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669782, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.