Treatment of Osteopenia With Melatonin (MelaOst)

University of Aarhus

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01690000

2011-AKA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: Female

Ages: 55 to 75 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

81 participants in 3 patient groups

Melatonin1

Active Comparator group

Description:

1 mg melatonin nightly

Treatment:

Drug: Melatonin

Melatonin3

Active Comparator group

Description:

3 mg melatonin given nightly

Treatment:

Drug: Melatonin

Placebo

Active Comparator group

Description:

Identical placebo given nightly

Treatment:

Drug: Melatonin