NCT04669782Leállítva
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 29.
Megadott ok: Logistics/management problems at the recruiting center
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Leállítva
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 99 (tényleges)
- Első benyújtás
- 2020. nov. 24.
- Kezdés
- 2020. nov. 24.
- Elsődleges befejezés
- 2024. júl. 4.
- Fő szponzor
- University of Milano Bicocca
- Betegségek
- Csontritkulás
- NCT-szám
- NCT04669782
Ki nem vehet részt
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Korábbi kezelés
- 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
Laborértékek
- 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.
Egyéb
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 65 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Istituto Ortopedico Galeazzi IRCCS | Milan | Olaszország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.