The effects of melatonin treatment on bone, marrow, sleep and arterial stiffness in postmenopausal women

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002934-34-DK

Enrollment

Registered

2020-09-03

Start date

2020-11-04

Completion date

Unknown

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis MedDRA version: 20.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Melatonin Product Code: Mt10 Pharmaceutical Form: Tablet INN or Proposed INN: Melatonin CAS Number: 73-31-4 Other descriptive name: MELATONIN Concentration unit: mg milligram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Postmenopausal women aged 55-75 years. Written consent to participate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Allergy towards study medicine • Allergy towards local anesthesia • Severely impaired renal function (eGFR 30 days) within the last year • Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) and/or alkaline phosphatase more the dobbed compared to upper limit of reference value. • Hypercalcemia (p-ion calcium > 1.32 nmol/l) • Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy). • Diseases affecting the calcium homeostasis including thyroid diseases. • Coagulationsfactor PP <0,6 • Regular use of medicine affecting the calciumhomeostasis; including diuretics, fenemal, lithium, antiepileptica. • SSRI-product with fluvoxamin • Treatment with hypnoticas • Treatment with beta-blocks • Ongoing treatment with melatonin • Continuously treatment with rifampicin • Severe malabsorption syndrome including gastric or intestinal resection. • Alcohol or drug abuse. • Smokers • Major medical or social problems that will be likely to preclude participation for 3 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: Changes in gene expression in mesenchymal stem cells;Secondary Objective: Changes in blood pressure and arterial stiffness Changes in quality of sleep Changes in biochemical markers Changes in BMD and bodycomposition;Primary end point(s): Changes in gene expression in mesenchymal stem cells;Timepoint(s) of evaluation of this end point: 2023	—

Secondary

Measure	Time frame
Secondary end point(s): Changes in blood pressure and arterial stiffness Changes in quality of sleep Changes in biochemical markers Changes in BMD and bodycomposition;Timepoint(s) of evaluation of this end point: 2023	—

Countries

Denmark

Contacts

Public ContactKlinik for knogleskørhed

Anne Kristine Amstrup

annekristineamstrup@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026