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Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients
Not Recruiting
Trial ID: NCT02451462
Purpose
Patients who undergo bone marrow transplant for different types of cancer are exposed to many
treatments such as steroids and whole body radiation. These treatments make the transplant
possible but also make their bones weaker and more prone to fractures which can be a source
of significant disability and decreased quality of life for cancer survivors. Our trial will
investigate whether giving one dose of Zoledronic acid (a commonly used drug given to
preserve bone mass in osteoporosis) before bone marrow transplant can protect from the bone
loss caused by the transplant procedures. The investigators are also interested in studying
the complex interactions of bone, muscle and fat which are greatly affected after bone marrow
transplant.
Official Title
Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients
Stanford Investigator(s)
Joy Wu
Associate Professor of Medicine (Endocrinology)
Eligibility
Inclusion Criteria:
- First allogeneic HSCT
- Age > 18 years
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Current or prior use of bone active medication (bisphosphonates, teriparatide,
selective estrogen receptor modulators, or Denosumab)
- Hypo- (Ca < 8.5 mg/dL) or hyper-calcemia (Ca > 10.5 mg/dL)
- Hyperthyroidism (TSH < 0.4 mIU/L and free T4 > 1.6 ng/dL)
- Hyperparathyroidism (PTH > 80 pg/mL)
- Estimated GFR < 35 ml/min/1.73 m2
- Other chronic disease unrelated to HSCT that may impact bone metabolism
- Osteoporosis: patients with a history of fragility fracture, or a Hip or Spine T score
of <-2.5 (these patients will be treated with Zoledronic Acid and followed, but
excluded from randomization)
Intervention(s):
drug: Zoledronic acid
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Rodrigo Valderrabano