Treatment of Osteopenia With Melatonin

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Melatonin

• Registration Number: NCT01690000
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-21
• Study Start: 2012-11
• Status Verified: 2013-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2016-02-01
• Results First Submitted QC: 2016-03-31
• Last Update Submitted: 2016-03-31
• Results First Posted: 2016-05-06
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin3	Melatonin	3 mg melatonin given nightly
Melatonin1	Melatonin	1 mg melatonin nightly
Placebo	Melatonin	Identical placebo given nightly

Primary Outcome Measures

Name	Time	Method
Changes in Bone Mineral Density (BMD)	baseline and end of study (after 12 months)	Effects of melatonin on BMD will be assessed through DXA-scans

Secondary Outcome Measures

Name	Time	Method
Changes in Calcium Homeostasis	baseline, after 3, 6, 9 months, and end of study (after 12 months)	Calcium homeostasis will be analyzed through blood and urines samples

Trial Locations

Locations (1)

Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA); 🇩🇰 Aarhus C, Denmark