NCT03925532

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

Completed Phase 2 Results posted Last updated 13 March 2024

What this trial tests

Phase 2 trial testing Denosumab in Allogeneic Hematopoietic Stem Cell Transplantation Recipient in 30 participants. Completed in 16 November 2022.

Timeline

19 December 2019

Primary endpoint
16 November 2022

16 November 2022

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	19 December 2019
Primary completion	16 November 2022
Estimated completion	16 November 2022
Sites	2 locations across United States

Drugs / interventions tested

• Denosumab (DENOSUMAB) — full drug profile →

Conditions studied

• Allogeneic Hematopoietic Stem Cell Transplantation Recipient — all drugs for Allogeneic Hematopoietic Stem Cell Transplantation Recipient →
• Osteopenia — all drugs for Osteopenia →
• Osteoporosis — all drugs for Osteoporosis →

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, any sex, with Allogeneic Hematopoietic Stem Cell Transplantation Recipient or Osteopenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Supportive Care (Denosumab)	-4.28	± 7.13

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

Group	Value	95% CI
Supportive Care (Denosumab)	0.04026	-0.11686 – 0.1973

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

Group	Value	95% CI
Supportive Care (Denosumab)	0.77	± 5.85

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

Group	Value	95% CI
Supportive Care (Denosumab)	-7.61	± 4.54

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

Group	Value	95% CI
Supportive Care (Denosumab)	-0.09690	-0.24883 – 0.05503

Mean Lumbar Spine Percent Change in BMD Secondary · 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.

Group	Value	95% CI
Supportive Care (Denosumab)	-4.04	± 5.46

Frequency of Bone Fractures Secondary · Up to 1 year post-HSCT

The number of participants with bone fractures tabulated overall

Group	Value	95% CI
Supportive Care (Denosumab)	0

Number of Participants That Experienced Any AE Secondary · 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.

Group	Value	95% CI
Supportive Care (Denosumab)	7

Adverse events — posted to ClinicalTrials.gov

Time frame: AE Time frame - Baseline, weekly until 30 day follow-up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Supportive Care (Denosumab)

Serious: 5/30 (17%)

Deaths: 7/30

Serious adverse events (4 terms)

Reaction	System	Supportive Care (Denosumab)
Fracture	Injury, poisoning and procedural complications	—
General disorders and administration site conditions - Other, specify	General disorders	—
Hip fracture	Injury, poisoning and procedural complications	—
Wrist fracture	Injury, poisoning and procedural complications	—

Other adverse events (2 terms — click to expand)

Reaction	System	Supportive Care (Denosumab)
Neutrophil count decreased	Investigations	—
Back pain	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Fracture, General disorders and administration site conditions - Other, specify, Hip fracture, Wrist fracture.

Data from ClinicalTrials.gov NCT03925532 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.