20 Participants Needed

Zoledronate for Bone Health After Bone Marrow Transplant

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Overseen ByBrady Landon
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether zoledronate, a medication, can improve bone health in children who have undergone a bone marrow transplant. The goal is to determine if this treatment can prevent bone problems and reduce pain post-transplant. It targets children aged 5 to 18 who are preparing for or recovering from a transplant and already have bone health issues. Participants must not have conditions like Fanconi anemia or low vitamin D levels and should be admitted to a specific hospital unit. The trial aims to ensure the treatment is safe and potentially effective for these young patients. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this potentially beneficial therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that zoledronate is likely to be safe for humans?

Research has shown that zoledronate, the drug used in this trial, has been tested in other studies. It strengthens bones and reduces bone damage. In treatments for bone cancer and multiple myeloma (a type of blood cancer), zoledronate is typically administered every 3 to 4 weeks.

Studies have found that most people tolerate it well, with few serious side effects. Common side effects include mild fever, tiredness, or aches, but these usually resolve on their own. Importantly, zoledronate is already approved for use in conditions like multiple myeloma, indicating it is generally safe.

Overall, while this trial explores a new use for zoledronate, existing research provides reassurance about its safety in humans.12345

Why do researchers think this study treatment might be promising?

Zoledronate is unique because it offers a new approach to enhancing bone health after a bone marrow transplant. Unlike standard treatments, which often include oral bisphosphonates or hormone therapies, Zoledronate is administered intravenously, allowing for direct and controlled delivery. This method helps ensure that the medication reaches its target efficiently and can be closely monitored for effectiveness and safety. Researchers are excited about Zoledronate because of its potential to provide quicker and more reliable improvements in bone density, which is crucial for patients recovering from transplants.

What evidence suggests that zoledronate might be an effective treatment for bone health after bone marrow transplant?

Research has shown that zoledronate, the treatment under study in this trial, can help prevent bone loss in individuals who have undergone bone marrow or stem cell transplants. One study found that zoledronic acid helps maintain bone health in adults at risk for osteoporosis post-transplant. Another study suggested that combining zoledronic acid with vitamin D and calcium may prevent bone loss in these patients. This is crucial because weak bones and fractures commonly occur after transplant procedures. Overall, zoledronate has shown promise in reducing the risk of bone problems in transplant patients.678910

Are You a Good Fit for This Trial?

This trial is for children and teenagers aged 5 to 18 who are either preparing for or recovering from a bone marrow transplant (HSCT) and have low bone density. They must be admitted to a CCHMC inpatient unit and can't participate if they've developed acute or chronic GVHD post-transplant.

Inclusion Criteria

I am between 5 and 18 years old, recovering from a stem cell transplant, and have GVHD.
I am between 5 and 18 years old, preparing for a stem cell transplant, and have low bone density for my age.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zoledronate intravenously to prevent bone disease and fractures

6 months
Inpatient stay for infusion and observation

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
DXA scans at baseline, +6 months, and +12 months

Long-term follow-up

Participants are monitored for long-term bone health outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Zoledronate

Trial Overview

The study tests the safety and potential effectiveness of early zoledronate treatment in preventing bone disease, fractures, and reducing pain in pediatric patients at high risk after HSCT.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ZoledronateExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Citations

Osteoporosis management in hematologic stem cell transplant

HSCT patients are living longer with concerns on long-term outcomes. Bone fragility and fracture are at the forefront for long-term morbidities ...

Zoledronic Acid in Preventing Osteoporosis in Patients ...

RATIONALE: Zoledronic acid, vitamin D, and calcium may prevent bone loss in patients who are undergoing donor stem cell transplant.

Intermittent Zoledronic Acid Prevents Bone Loss in Adults ...

Intermittent ZA is effective in preserving long-term bone health in adult alloHCT recipients at risk for osteoporosis. Key Words. Osteoporosis · Zoledronic acid ...

Bone Health Management After Hematopoietic Cell ...

Bone health disturbances commonly occur after hematopoietic cell transplantation (HCT) with loss of bone mineral density (BMD) and avascular necrosis (AVN) ...

Bone Health and Other Endocrine Issues after Transplant ...

Bone loss is very common after a bone marrow or stem cell transplant. This presentation discusses what causes bone loss, who's at risk, and how to prevent ...

Zoledronic acid (intravenous route) - Side effects & uses

For bone cancer and multiple myeloma, this medicine is usually given every 3 to 4 weeks. This treatment will continue until your body responds to the medicine.

Safety and tolerability of zoledronic acid and other ... - PMC

Several randomized control trials have demonstrated that NBPs significantly improve bone mineral density, suppress bone turnover, and reduce the incidence of ...

Zoledronate to Prevent Bone Health Complications in ...

The purpose of this pilot study is to investigate the safety and preliminarily assess efficacy of early intervention with zoledronate in high ...

Yearly Long-Acting Zoledronic Acid (Reclast) Is Safe and ...

Yearly Long-Acting Zoledronic Acid (Reclast) Is Safe and Effective for Treatment of Bone Loss after Hematopoietic Stem Cell Transplantation.

Zometa (zoledronic acid)

Zometa (zoledronic acid) is a medication known as a bisphosphonate that prevents bone damage in multiple myeloma patients.