Treatment of Osteopenia With Melatonin (MelaOst)

March 31, 2016 updated by: University of Aarhus

Treatment of Osteopenia With Melatonin: Effects on BMD, Muscle Strength and Quality of Life

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Melatonin is known for its regulation of circadian rhythm. The production falls with age, which explains why elderly may have disturbed sleep patterns. Laboratory study and animal experimental studies suggests that melatonin also may protect against bone loss through increased osteoblast- and inhibited osteoclast activity. However, so far human studies have not been performed.

Design and patients: Double blinded randomised controlled study. Eighty post-menopausal women (aged 55-75) with osteopenia are randomized to receive 1mg, 3mg or placebo (daily - at night time) for 12 months.

Methods and results: Effects of melatonin on BMD, bone- structure and mass will be assessed through DXA-scans, pQCT, and QCT. Quality of life, sleep, and activity level will be assessed though questionnaires. Calcium homeostasis will be analyzed through blood and urines samples. As safety parameters, balance and muscle function will also be performed.

Conclusion: Expected improvements in BMD, quality of life and sleep.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women between 55 and 75 years.
  • Osteopenia 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

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 doubled compared to upper limit of reference value).
  • Coagulation factors PP <0.6
  • 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 untreated thyroid diseases.
  • Regular use of medicine affecting the calcium homeostasis; including diuretics, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Melatonin1
1 mg melatonin nightly
Drug: Melatonin
1 or 3 mg of melatonin PO each night for 12 months
Active Comparator: Melatonin3
3 mg melatonin given nightly
Drug: Melatonin
1 or 3 mg of melatonin PO each night for 12 months
Active Comparator: Placebo
Identical placebo given nightly
Drug: Melatonin
1 or 3 mg of melatonin PO each night for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Bone Mineral Density (BMD)
Time Frame: baseline and end of study (after 12 months)
Effects of melatonin on BMD will be assessed through DXA-scans
baseline and end of study (after 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Calcium Homeostasis
Time Frame: baseline, after 3, 6, 9 months, and end of study (after 12 months)
Calcium homeostasis will be analyzed through blood and urines samples
baseline, after 3, 6, 9 months, and end of study (after 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Anne Kristine Amstrup, MD, Osteoporoseklinikken, Dept. of Endocrinology and Internal Medicine (MEA) Aarhus University Hospital, Tage-Hansens Gade 2, AArhus, DEnmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-AKA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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