| | Study | Journal | Country | Design | Sample size | Mean age (years) | Relevant outcomes | | Trial group | Control group | Trial group | Control group |
| | Amstrup 2015 [26, 27] | J Pineal Res/ Nutr J | Denmark | RCT, DB | 40 | 41 | 62.4 ± 3.5 | 62.9 ± 4.7 | BMD, adverse events | | Kotlarczyk 2012 [15] | J Pineal Res | USA | RCT, DB | 13 | 5 | 50.3 ± 3.0 | 47.5 ± 2.0 | T-score, osteocalcin | | Maria 2017 [28] | Aging | USA | RCT, DB | 11 | 11 | 60 ± 1.73 | 57 ± 1.41 | BMD, T-score, osteocalcin, adverse events |
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| | Study | Inclusion criteria | Exclusion criteria | Identifier | Duration |
| | Amstrup 2015 [26, 27] | (1) Postmenopausal women between 55 and 75 years
(2) Osteopenia verified by DXA-scans of total hip or lumbar spine (T-score between -1 and -2.5)
(3) Written informed consent after oral and written information | (1) Severely impaired renal function (plasma creatinine >60 eGFR ml/l)
(2) Severely impaired hepatic function (plasma alanine aminotransferase (ALAT) and/or alkaline phosphatase more than the doubled compared to upper limit of reference value)
(3) Coagulation factors PP <0.6
(4) Hypercalcemia (p-ion calcium > 1.32 nmol/l)
(5) Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since the last therapy)
(6) Diseases affecting the calcium homeostasis including untreated thyroid diseases
(7) Regular use of medicine affecting the calcium homeostasis, including diuretics, lithium, antiepileptics, and glucocorticoids
(8) SSRI-product with fluvoxamine
(9) Treatment with carbamazepine
(10) Treatment with rifampicin
(11) Severe malabsorption syndrome including gastric or intestinal resection
(12) Alcohol or drug abuse
(13) Smokers
(14) Major medical or social problems that will be likely to preclude participation for one year | NCT01690000 | 12 months | | Kotlarczyk 2012 [15] | (1) Women of age 45 or older
(2) Experiencing an irregular menstrual cycle
(3) Having had at least one menstrual period in the past 6 months | (1) Current use of hormone therapy or birth control
(2) Current use of prescription medications for thinning bones, sleep, depression, or regulation of blood pressure
(3) Use of medication for thinning bones within the past three months
(4) Current use of steroid medications or chronic use in the past 6 months (diagnosis of osteoporosis)
(5) Uncontrolled high blood pressure, liver disease, and medical conditions such as hyperparathyroidism or cancer, severe sleep apnea, chronic obstructive pulmonary disease, and severe lactose intolerance
(6) Current use of tobacco | NCT01152580 | 6 months | | Maria 2017 [28] | (1) Being postmenopausal with osteopenia (T-score between -1 and -2.5)
(2) Willingness to participate in a 12-month study
(3) Willingness to take daily therapy right before bed
(4) Willingness to undergo testing of bone markers and other biochemical parameters
(5) Providing a self-assessment on quality of life throughout the program | (1) Being diagnosed with osteoporosis (T-score less than -2.5)
(2) Being osteopenic as a consequence of other medical conditions such as hyperparathyroidism, metastatic bone disease, multiple myeloma, or chronic steroid use
(3) Current use of hormone therapy or birth control
(4) Current use of prescription medications for osteoporosis, sleep, depression, anxiety, ulcerative colitis, or regulation of blood pressure
(5) Current use of steroid medications or chronic use in the past 6 months
(6) Other medical conditions such as uncontrolled high blood pressure, liver disease, severe sleep apnea, and chronic obstructive pulmonary disease
(7) Current use of tobacco | NCT01870115 | 12 months |
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