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Completed

NCT Number: NCT03925532

Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant

This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.

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Key information

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Recipient Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Osteoporosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Roswell Park Cancer Institute, Buffalo, New York, United States

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

I. To evaluate the efficacy and safety of denosumab therapy for the treatment of bone loss in patients who have received an allogeneic hematopoietic stem cell transplant.

OUTLINE:

Patients receive 2 doses of denosumab subcutaneously (SC) between days 70-130 and days 250-310 after allogeneic hematopoietic stem cell transplant in the absence of disease progression or unacceptable toxicity.

After completion of study treatment patients are followed up at 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient has undergone an Allogeneic Hematopoietic Stem Cell Transplant
  • The patient has completed a base line dual x-ray absorptiometry (DXA) scan =< 6 months prior to transplantation
  • The patient has completed a post-transplant DXA scan at day 100 (+/- 30 days) or up to 6 months post transplantation
  • The patient has completed and passed a dental clearance exam up to 6 months prior to transplant or 6 months after transplant
  • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion criteria

  • The patient has a history of a hypersensitivity reaction to denosumab
  • The patient has a history of osteonecrosis of the jaw
  • The patient has predisposing risk factors for hypocalcemia including the following:
  • Hypoparathyroidism
  • Creatinine clearance (CrCl) < 30 mL/min
  • Dialysis
  • Malabsorption syndrome
  • The patient has history of any bone fracture =< 30 days prior to denosumab therapy
  • Pregnant or nursing female patients.
  • The patient has clinically significant GVHD leading to hospitalization at the time of denosumab dose per prescriber discretion.
  • The patient has clinically significant infection leading to hospitalization at the time of denosumab dose (excluding hospitalization due to complexity of treatment leading to inability to treat outpatient, ie. Foscarnet) per prescriber discretion
  • The patient is unwilling or unable to follow protocol requirements
  • The patient has any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug including relapsed malignancy

Treatment and study plan

Denosumab

Biological

Given SC

Other names: AMG 162, AMG-162, Prolia, Xgeva

Primary outcomes

  1. Mean Total Hip Percent Change in Bone Mineral Density (BMD)

    Time frame: At baseline and 465 days post-HSCT

    Day 0 dual x-ray absorptiometry (DXA) scan and day 465 DXA scan will be compared based on the percent change in BMD in the Total hip in allogeneic HSCT patients who have experienced either at least 5% BMD loss between baseline (pre- HSCT) and day + 100 post-HSCT, or who have osteopenia or osteoporosis at either the pre-bone marrow transplant or day + 100 DXA scan.

  2. Slope in Hip Bone Mineral Density (g/cm^2 Per Day) Regressed on Time in Dual

    Time frame: From the time of enrollment up to 465 days post-HSCT

    Parameter estimate of the slope of the regression model of the hip bone mineral density change at day 465 post-HSCT regressed on the enrollment BMD levels.

  3. Mean Lumbar Spine Percent Change in Bone Mineral Density (BMD)

    Time frame: At baseline and 465 days post-HSCT

    Day 0 dual x-ray absorptiometry (DXA) scan and day 465 DXA scan will be compared based on the percent change in BMD in lumbar spine in allogeneic HSCT patients who have experienced either at least 5% BMD loss between baseline (pre- HSCT) and day + 100 post-HSCT, or who have osteopenia or osteoporosis at either the pre-bone marrow transplant or day + 100 DXA scan.

  4. Mean Total Hip Percent Change in Bone Mineral Density (BMD)

    Time frame: At baseline, at time of enrollment (day 100 post-hematopoietic stem cell transplantation [HSCT])

    Day 100 dual x-ray absorptiometry (DXA) scan will be compared based on the percent change in BMD in the Total hip in allogeneic HSCT patients who have experienced either at least 5% BMD loss between baseline (pre- HSCT) and day + 100 post-HSCT, or who have osteopenia or osteoporosis at either the pre-bone marrow transplant or day + 100 DXA scan.

  5. Slope in Lumbar Spine Bone Mineral Density (g/cm^2 Per Day) Regressed on Time in Dual

    Time frame: From the time of enrollment up to 465 days post-HSCT

    Parameter estimate of the slope of the regression model of the lumbar spine bone mineral density change at day 465 post-HSCT regressed on the enrollment BMD levels.

Secondary outcomes

  1. Mean Lumbar Spine Percent Change in BMD

    Time frame: Baseline up to 100 days post-HSCT

    Day 100 dual x-ray absorptiometry (DXA) scan will be compared based on the percent change in BMD in the lumbar spine in allogeneic HSCT patients who have experienced either at least 5% BMD loss between baseline (pre- HSCT) and day + 100 post-HSCT, or who have osteopenia or osteoporosis at either the pre-bone marrow transplant or day + 100 DXA scan.

  2. Frequency of Bone Fractures

    Time frame: Up to 1 year post-HSCT

    The number of participants with bone fractures tabulated overall

  3. Number of Participants That Experienced Any AE

    Time frame: Up to 30 days

    Including but not limited to the following: Injection/hypersensitivity related reactions; osteonecrosis of the jaw; graft versus host disease. Will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 and tabulated by grade.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • Amgen

Registry information

Official study title

A Phase II Multicenter, Single Arm, Open-Label Trial to Evaluate the Efficacy and Safety of Denosumab in Treatment of Post-Allogenic Hematopoietic Stem Cell Transplant Bone Loss

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2019
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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