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

Study Overview
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Brief Summary
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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.

Detailed Description
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Primary Objective: To determine whether a single dose of zoledronic acid pre-transplant will prevent HSCT-related bone loss without impeding engraftment, compared with placebo. Secondary Objectives: To identify bone and muscle deficits and alterations in fat distribution prior to HSCT, compared with healthy controls.

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

Conditions
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Hematopoietic Stem Cell Transplant, Bone Marrow Transplant

Intervention / Treatment
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* Drug: Zoledronic acid


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoledronic acid arm<br>Zoledronic acid | Drug: Zoledronic acid<br> <br> |
| No Intervention: placebo arm<br>placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change in Bone Mineral Density at the Femoral Neck |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematopoietic stem cell transplant, bone marrow transplant