Treatment of Osteopenia With Melatonin

NCT ID: NCT01690000

Last Updated: 2016-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Melatonin1

1 mg melatonin nightly

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DRUG

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

Melatonin3

3 mg melatonin given nightly

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DRUG

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

Placebo

Identical placebo given nightly

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DRUG

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

Interventions

Melatonin

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Kristine Amstrup, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)

Aarhus C, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 26424587 (View on PubMed)

Other Identifiers

2011-AKA

Identifier Type: -

Identifier Source: org_study_id