N/A Completed N=81 Randomized Quadruple-blind Treatment

Treatment of Osteopenia With Melatonin

Osteoporosis

Source: ClinicalTrials.gov NCT01690000 ↗

Enrolled (actual)

Serious AEs

14.8%

Results posted

May 2016

Primary outcomePrimary: Changes in Bone Mineral Density (BMD) — -0.05; -1.45 percentage of change in BMD — p=<0.05

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Bone Mineral Density (BMD)	-0.05; -1.45	<0.05 sig
SECONDARY Changes in Calcium Homeostasis	—	—

Eligibility 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01690000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.