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Trial record 1 of 1 for:    melaost
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Treatment of Osteopenia With Melatonin (MelaOst)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01690000
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Melatonin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Osteopenia With Melatonin: Effects on BMD, Muscle Strength and Quality of Life
Study Start Date : November 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: Melatonin1
1 mg melatonin nightly
Drug: Melatonin
1 or 3 mg of melatonin PO each night for 12 months

Active Comparator: Melatonin3
3 mg melatonin given nightly
Drug: Melatonin
1 or 3 mg of melatonin PO each night for 12 months

Active Comparator: Placebo
Identical placebo given nightly
Drug: Melatonin
1 or 3 mg of melatonin PO each night for 12 months




Primary Outcome Measures :
  1. Changes in Bone Mineral Density (BMD) [ Time Frame: baseline and end of study (after 12 months) ]
    Effects of melatonin on BMD will be assessed through DXA-scans


Secondary Outcome Measures :
  1. Changes in Calcium Homeostasis [ Time Frame: baseline, after 3, 6, 9 months, and end of study (after 12 months) ]
    Calcium homeostasis will be analyzed through blood and urines samples



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690000


Locations
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Denmark
Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Anne Kristine Amstrup, MD Osteoporoseklinikken, Dept. of Endocrinology and Internal Medicine (MEA) Aarhus University Hospital, Tage-Hansens Gade 2, AArhus, DEnmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01690000    
Other Study ID Numbers: 2011-AKA
First Posted: September 21, 2012    Key Record Dates
Results First Posted: May 6, 2016
Last Update Posted: May 6, 2016
Last Verified: April 2013
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants