Treatment of Osteopenia With Melatonin

Osteoporosis Clinical Trial

— MelaOst  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690000
• Other study ID #: 2011-AKA
• Status: Completed
• Phase: N/A
• First received: June 28, 2012
• Last updated: June 3, 2014
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Melatonin
1 or 3 mg of melatonin PO each night for 12 months

Locations

Country	Name	City	State
Denmark	Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in bone mineral density (BMD)	Effects of melatonin on BMD will be assessed through DXA-scans	baseline and end of study (after 12 months)	No
Secondary	Quality of life and sleep	Quality of life and sleep will be assessed through SF36v2 questionaire, WHO-5 Well being index, and quality of sleep through Pittsburgh Sleep Quality Questionaire.	At baseline and end of study (after 12 months)	No
Secondary	Changes in calcium homeostasis	Calcium homeostasis will be analyzed through blood and urines samples	baseline, after 3, 6, 9 months, and end of study (after 12 months)	No
Secondary	Effect on muscle and balance function	As safety parameters, balance and muscle function be performed using a dynamometer and a stadiometer (Meititur Ltd, Finland)	Baseline and end of study (after 12 months)	No
Secondary	Glucosehomeostasis	Changes in glucose levels and HbA1c due to study drug	baseline, 3,6, 9, and 12 months	No