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Treatment of Osteopenia With Melatonin (MelaOst)

Primary Purpose

Osteoporosis

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Melatonin

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Melatonin1

Melatonin3

Placebo

Arm Description

1 mg melatonin nightly

3 mg melatonin given nightly

Identical placebo given nightly

Outcomes

Primary Outcome Measures

Changes in Bone Mineral Density (BMD)

Effects of melatonin on BMD will be assessed through DXA-scans

Secondary Outcome Measures

Changes in Calcium Homeostasis

Calcium homeostasis will be analyzed through blood and urines samples

Full Information

NCT ID

NCT01690000

First Posted

June 28, 2012

Last Updated

March 31, 2016

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT01690000

Brief Title

Treatment of Osteopenia With Melatonin

Acronym

MelaOst

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Melatonin1

Arm Type

Active Comparator

Arm Description

1 mg melatonin nightly

Arm Title

Melatonin3

Arm Type

Active Comparator

Arm Description

3 mg melatonin given nightly

Arm Title

Placebo

Arm Type

Active Comparator

Arm Description

Identical placebo given nightly

Intervention Type

Drug

Intervention Name(s)

Melatonin

Intervention Description

1 or 3 mg of melatonin PO each night for 12 months

Primary Outcome Measure Information:

Title

Changes in Bone Mineral Density (BMD)

Description

Effects of melatonin on BMD will be assessed through DXA-scans

Time Frame

baseline and end of study (after 12 months)

Secondary Outcome Measure Information:

Title

Changes in Calcium Homeostasis

Description

Calcium homeostasis will be analyzed through blood and urines samples

Time Frame

baseline, after 3, 6, 9 months, and end of study (after 12 months)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Kristine Amstrup, MD

Organizational Affiliation

Osteoporoseklinikken, Dept. of Endocrinology and Internal Medicine (MEA) Aarhus University Hospital, Tage-Hansens Gade 2, AArhus, DEnmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

26424587

Citation

Amstrup AK, Sikjaer T, Mosekilde L, Rejnmark L. The effect of melatonin treatment on postural stability, muscle strength, and quality of life and sleep in postmenopausal women: a randomized controlled trial. Nutr J. 2015 Sep 30;14:102. doi: 10.1186/s12937-015-0093-1.

Results Reference

derived

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Treatment of Osteopenia With Melatonin

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