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

Phase 1

• Conditions: Osteoporosis; Therapeutic area: Diseases [C] - Hormonal diseases [C19]; MedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2020-002934-34-DK
• Lead Sponsor: Aarhus University Hospital, dept. of Diabetes and Hormonal diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-03
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 40

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

•Allergy towards study medicine
•Allergy towards local anesthesia
•Severely impaired renal function (eGFR <59 ml/l).
•Treatment with antiresorptives within 5 years
•Treatment with postmenopausal hormons within the last 2 years
•Systemic treatment with glucocorticoids (duration >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Changes in gene expression in mesenchymal stem cells;Secondary Objective: Changes in blood pressure and arterial stiffness<br>Changes in quality of sleep<br>Changes in biochemical markers<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in blood pressure and arterial stiffness<br>Changes in quality of sleep<br>Changes in biochemical markers<br>Changes in BMD and bodycomposition;Timepoint(s) of evaluation of this end point: 2023