N/A
N=81
Treatment of Osteopenia With Melatonin
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01690000 ↗Enrolled (actual)
81
Serious AEs
14.8%
Results posted
May 2016
Primary outcome: Primary: Changes in Bone Mineral Density (BMD) — -0.05; -1.45 percentage of change in BMD — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Melatonin (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- University of Aarhus
- Primary completion
- Jun 2014
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 |
— | — |
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.
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.
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.