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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01016093
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent.
* Patients must be 18 years old and over.
* Diagnosed with beta-thalassemia major
* Scheduled for allogenic bone marrow transplantation
* The date of randomization must be no more than 1 week after BMT.
* Patients must be accessible for follow-up.
* Life expectancy of at least 12 months from randomization.
Exclusion Criteria:
* Patients with any clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.
* Patients with a history of fracture with low-density or no associated trauma.
* Osteoporotic patients with T-score \<= -2.5
* Previous treatment with a bisphosphonate.
* Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 30 ml/minute or less.
* Pregnancy and lactation.
* Women of childbearing potential not on a medically recognized form of contraception.
* Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study.
* Subjects participating simultaneously in studies with unapproved drugs, indications or treatment regimens.
* Known hypersensitivity to zoledronic acid or bisphosphonates.
* Patients with prior exposure to anabolic steroids, growth hormone, Parathyroid Hormone (PTH) or other drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate).
* Serious intercurrent illness
* History of metabolic bone diseases
* History of corticosteroid treatment for other causes
* History of antiepileptic drug treatment
* History or surgery at the lumbosacral spine, with or without implantable devices.
* Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA.
* Mental illness that precludes the patient from giving informed consent.
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01016093
Study Brief:
Protocol Section:
NCT01016093