NCT01690000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

April 1, 2013

Enrollment Period

1.6 years

First QC Date

June 28, 2012

Results QC Date

February 1, 2016

Last Update Submit

March 31, 2016

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Changes in Calcium Homeostasis

    baseline, after 3, 6, 9 months, and end of study (after 12 months)

Study Arms (3)

Melatonin1

ACTIVE COMPARATOR

1 mg melatonin nightly

Drug: Melatonin

Melatonin3

ACTIVE COMPARATOR

3 mg melatonin given nightly

Drug: Melatonin

Placebo

ACTIVE COMPARATOR

Identical placebo given nightly

Drug: Melatonin

Interventions

MelatoninDRUG

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

Melatonin1Melatonin3Placebo

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26424587DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Anne Kristine Amstrup
Organization
Aarhus University
anne_kristine_am@hotmail.com
4578467681

Study Officials

  • Anne Kristine Amstrup, MD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2012

First Posted

September 21, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 6, 2016

Results First Posted

May 6, 2016

Record last verified: 2013-04

Locations

DK(1)