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:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT00409032
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women (at least 12 months since last menstruation).
* BMD (L2-4) T-score between -1 and -3 (at least 20% of the enrolled patients must have a BMD (L2-4) T-score below -2,5).
* 50 years of age.
* BMI\<30 kg/m2.
* Total S-Ca level within normal range.
* Ability to read and understand the information given.
* The patient has signed an informed consent form according to ICH E6 and local requirements before any study specific procedure is carried out.
* Ability to comply with study procedures.
Exclusion Criteria:
* History of prior fragility fracture (any fracture in wrist, hip or spine appearing after 40 years of age).
* History of alcohol or drug abuse.
* Metabolic bone disease (e.g. pagets disease, bone cancer).
* History of VTE/DVT.
* History of kidney transplant.
* Bilateral oophorectomy.
* Relevant and treated reduced kidney or liver function.
* Any malignancy within the last 5 years (except basal cell carcinoma)
* Any chronic condition likely to affect absorption (e.g. Crohns disease, gluten enteropathy).
* Known genetic pre-disposition to VTE/DVT
* Known hypersensitivity to any of the active substances or excipients.
* 25-OH-vitamin D level below 25 nmol/L
* Any previous treatment with bisphosphonates, Strontium or fluoride.
* Treatment during the last 3 months affecting calcium balance or bone metabolism (e.g. thiazides, corticosteroids, calcitonin, HRT, SERMs, PTH, phosphorus).
* Treatment during the last week with tetracycline, ciprofloxacin or loop diuretics.
* PTH out of normal range
* Use of any drug known to influence the coagulation process (aspirin and other NSAID allowed)
* Prothrombin time out of normal range (sec or INR)
* Inclusion in another clinical study within 30 days before randomization or during this study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT00409032
Study Brief:
Protocol Section:
NCT00409032