Treatment of osteopenia with melatonin: Effects on bone mineral density, muscle strength, and quality of life

Treatment of osteopenia with melatonin: Effects on BMD, muscle strength and quality of life - MelaOst

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004670-28-DK

Enrollment

Registered

2012-04-25

Start date

2012-04-25

Completion date

Unknown

Last updated

2016-01-11

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

Conditions

Osteoporosis MedDRA version: 14.1 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Melatonin Product Code: Mt130 Pharmaceutical Form: Tablet for oral suspension INN or Proposed INN: Melatonin CAS Number: 73-31-4 Current Sponsor code: Mt13 Other descriptive name: MELATO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Postmenopausal women between 55 and 75 years. •Osteopeni verified by DXA-scans of total hip or lumbar spine (t-score between -1 and -2.5) •Written informed consent after oral and written information 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: •Severely impaired renal function (plasma creatinine >60 eGFR ml/l). •Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) and/or alkaline phosphatase more the dobbed compared to upper limit of reference value). •Coagulation factors PP 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 untreated thyroid diseases. •Regular use of medicine affecting the calciumhomeostasis; including diuretics, fenemal, lithium, antiepileptica, glucosteroids. •SSRI-product with fluvoxamin. •Treatment with carbamazepin •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 one year.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.;Secondary Objective: •BMD: Effects of treatment on BMD are determined by DXA-, QCT-, and pQCT-scans. •Muscle- and balance function: Effects of treatment on muscle strength and balance function are determined using a dynamometer and a stadiometer (Meititur Ltd, Finland). •Quality of life: Effect of treatment on indices of quality of life is assessed using the SF-36v2- and the WHO-Five Well-Being Index (WHO-5)-survey. Furthermore, quality of sleep (Pittsburgh Quality Sleep Index) and physical activity scale (PAS) is also assessed. •Calcium homeostasis, bone metabolism, and body composition. Effects of treatment are assessed by measurements of calcitropic hormones, and biochemical markers of bone turnover. ;Primary end point(s): Increase in BMD ;Timepoint(s) of evaluation of this end point: End of year 2014	—

Measure

Time frame

Main Objective: The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.;Secondary Objective: •BMD: Effects of treatment on BMD are determined by DXA-, QCT-, and pQCT-scans. •Muscle- and balance function: Effects of treatment on muscle strength and balance function are determined using a dynamometer and a stadiometer (Meititur Ltd, Finland). •Quality of life: Effect of treatment on indices of quality of life is assessed using the SF-36v2- and the WHO-Five Well-Being Index (WHO-5)-survey. Furthermore, quality of sleep (Pittsburgh Quality Sleep Index) and physical activity scale (PAS) is also assessed. •Calcium homeostasis, bone metabolism, and body composition. Effects of treatment are assessed by measurements of calcitropic hormones, and biochemical markers of bone turnover. ;Primary end point(s): Increase in BMD ;Timepoint(s) of evaluation of this end point: End of year 2014

—

Secondary

Measure	Time frame
Secondary end point(s): Increase in quality of life, sleep pattern and physical activity level;Timepoint(s) of evaluation of this end point: End of year 2014	—

Countries

Denmark

Contacts

Public ContactOsteoporoseklinikken

Osteoporoseklinikken

annekristineamstrup@gmail.dk00457846 7681

Outcome results

None listed

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