Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT01690000
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 \<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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT01690000
Study Brief:
Protocol Section:
NCT01690000