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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT03174366
Eligibility Criteria:
Inclusion Criteria:
* Men or women \> 30 years old
* Subject is able and willing to comply with study procedures, and is able to give signed and dated consent
* Subject meets criteria for diagnosis of Diabetes Mellitus Type 1 or 2, active Charcot neuroarthropathy, and peripheral neuropathy
* Subjects with serum calcium or albumin-adjusted serum calcium ≥2.0 mmol/L (8.0mg/dL)
Exclusion Criteria:
* Unable to provide signed and dated consent.
* Charcot neuroarthropathy of the ipsilateral lower extremity, diagnosed over 1 month prior.
* Prior foot or ankle surgery of the ipsilateral lower extremity.
* Prior amputation at any level of either lower extremity.
* Prior foot or ankle fracture of the ipsilateral lower extremity unrelated to the current acute CN episode.
* Currently has any of the following:
1. Infection
2. Foot ulceration
3. Hypocalcemia
4. Creatinine clearance less than 30 mL/min or on dialysis
5. Pre-existing disturbance of mineral metabolism (e.g., hypoparathyroidism unstable on therapy, thyroid or parathyroid surgery, vitamin D deficiency, malabsorption syndromes, excision of small intestine, history of diseases affecting bone metabolism) that has not been effectively corrected or treated.
* Have undergone revascularization procedures of the lower extremities.
* Female subjects who are pregnant or planning to breastfeed should not participate in this study.
* Determined to have poor oral hygiene after dental screening or are at increased risk for developing osteonecrosis of the jaw.
* History of osteonecrosis of the jaw.
* History of tooth extraction or other dental surgery within the prior 6 months.
* Invasive dental work planned in the next 2 years.
* Have a known hypersensitivity to Prolia.
* Known use of a bone active medication within the 6 months prior to enrollment.
* Liver disease, defined as AST \> 2.0x ULN, ALT \> 2.0x ULN, TBL \> 1.5x ULN.
* Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Study:
NCT03174366
Study Brief:
Protocol Section:
NCT03174366