Treatment of Osteopenia With Melatonin: Effects on BMD, Muscle Strength and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Changes in Bone Mineral Density (BMD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
- •Major medical or social problems that will be likely to preclude participation for one year.
研究组 & 干预措施
Melatonin1
1 mg melatonin nightly
干预措施: Melatonin (Drug)
Melatonin3
3 mg melatonin given nightly
干预措施: Melatonin (Drug)
Placebo
Identical placebo given nightly
干预措施: Melatonin (Drug)
结局指标
主要结局
Changes in Bone Mineral Density (BMD)
时间窗: baseline and end of study (after 12 months)
Effects of melatonin on BMD will be assessed through DXA-scans
次要结局
- Changes in Calcium Homeostasis(baseline, after 3, 6, 9 months, and end of study (after 12 months))