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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03435094
Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal women (at least 5 years after natural / surgical menopause).
* Patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months.
* Available BTMs (s-CTX), biochemistry (calcium, phosphate, 25-OH vit D, PTH, creatinine) and DXA (lumbar spine, total hip and femoral neck) at the initiation of the treatment.
* Ability to sign an informed patient consent
Exclusion Criteria:
* Patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg.
* Any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption
* Metabolic or cancer bone disease
* Contra-indications to bisphosphonates according to product labelling
* Known or suspected allergy to study product(s) or related products
* Inability to sign an informed consent
* Previous participation in this study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
55 Years
Maximum Age:
90 Years
Study:
NCT03435094
Study Brief:
Protocol Section:
NCT03435094