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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT03925532
Eligibility Criteria:
Inclusion Criteria:
* The patient has undergone an Allogeneic Hematopoietic Stem Cell Transplant
* The patient has completed a base line dual x-ray absorptiometry (DXA) scan =\< 6 months prior to transplantation
* The patient has completed a post-transplant DXA scan at day 100 (+/- 30 days) or up to 6 months post transplantation
* The patient has completed and passed a dental clearance exam up to 6 months prior to transplant or 6 months after transplant
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* The patient has a history of a hypersensitivity reaction to denosumab
* The patient has a history of osteonecrosis of the jaw
* The patient has predisposing risk factors for hypocalcemia including the following:
* Hypoparathyroidism
* Creatinine clearance (CrCl) \< 30 mL/min
* Dialysis
* Malabsorption syndrome
* The patient has history of any bone fracture =\< 30 days prior to denosumab therapy
* Pregnant or nursing female patients.
* The patient has clinically significant GVHD leading to hospitalization at the time of denosumab dose per prescriber discretion.
* The patient has clinically significant infection leading to hospitalization at the time of denosumab dose (excluding hospitalization due to complexity of treatment leading to inability to treat outpatient, ie. Foscarnet) per prescriber discretion
* The patient is unwilling or unable to follow protocol requirements
* The patient has any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug including relapsed malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03925532
Study Brief:
Protocol Section:
NCT03925532