Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| End Date: | September 2018 |
Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients
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.
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.
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.
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.
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)
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
Stanford, California 94305
(650) 725-3900
Principal Investigator: Joy Wu
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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