Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients

Trial ID or NCT#

NCT02451462

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - First allogeneic HSCT - Age > 18 years - Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
  1. - 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)

Investigator(s)

Joy Wu
Joy Wu
Endocrinologist
Associate Professor of Medicine (Endocrinology)

Contact us to find out if this trial is right for you.

Contact

Rodrigo Valderrabano