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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT02091492
Eligibility Criteria:
Inclusion Criteria:
* recent proximal 2-segment humerus fracture (0-8 days post fracture)
* no surgical treatment at fractured site
* signed informed consent
* postmenopausal female and male patients aged 60 - 85 years
* established osteoporosis as defined by BMD measured with DXA-technology (dual energy X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip
Exclusion Criteria:
* Hypersensitivity to the active substance or to any of the excipients.
* Pre-existing hypercalcemia
* Severe renal impairment (eGFR\< 35ml/min)
* Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
* Unexplained elevations of alkaline phosphatase
* Prior external beam or implant radiation therapy to the skeleton
* Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
* any prior antiresorptive therapy (oral/intravenous bisphosphonates, RANKL-antibody, SERMs)
* any prior strontium ranelate therapy
* any prior TPTD of PTH 1-84 therapy
* malignancies ≤ 5 years except basalioma
* hypo-/hypercalcemia
* baseline 25-OH vitamin D3 level ≤10 ng/ml
* prosthesis at fractured and contralateral humerus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT02091492
Study Brief:
Protocol Section:
NCT02091492