Phase 3
Completed N=90
Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients
Source: ClinicalTrials.gov NCT01377467 ↗Enrolled (actual)
90
Serious AEs
66.7%
Results posted
Apr 2016
Primary outcomePrimary: Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 — 4.5; -0.3 percent change — p=<0.001
◆ Published Evidence
Highly cited
104citations · ~10 / year
Effect of Twice-Yearly Denosumab on Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients: A Randomized Controlled Trial.
Summary
The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality.
* Trial with medicinal product
Linked Publications (2)
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Effect of Twice-Yearly Denosumab on Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients: A Randomized Controlled Trial.
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Interventions for BK virus infection in kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 |
4.5; -0.3 | <0.001 sig |
| SECONDARY Percent Change in BMD at the Total Hip From Baseline to Month 12 |
2.3; 0.5 | 0.035 sig |
| SECONDARY Percent Change in BMD at the Femoral Neck From Baseline to Month 12 |
1.1; 0.8 | 0.380 |
| SECONDARY Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6 |
2.9; -1.5 | <0.001 sig |
| SECONDARY Percent Change in BMD at the Total Hip From Baseline to Month 6 |
1.4; -0.3 | 0.009 sig |
| SECONDARY Percent Change in BMD at the Femoral Neck From Baseline to Month 6 |
1.0; -0.8 | 0.064 |
| SECONDARY Beta-CTX at Baseline and Months 3, 6 and 12 |
0.635; 0.772; 0.129; 0.590; 0.204; 0.612 | <0.001 sig |
| SECONDARY P1NP at Baseline and Months 3, 6 and 12 |
61.222; 77.808; 40.976; 108.699; 35.347; 107.072 | <0.001 sig |
Eligibility Criteria
The key inclusion criteria are:
- Male or female adult de novo kidney, kidney-pancreas or kidney-islet, or kidney-liver transplant recipients
- Functioning graft within 28 days after transplantation (creatinine having decreased to 200 micromol/l at baseline
- Evidence of early acute rejection, either suspected clinically and/or proven by biopsy
- Presence of severe osteoporosis as evidenced by a T score 800 ng/l or 2.7 mmol/l)
- Steroid-free de novo immunosuppression scheme
Data sourced from ClinicalTrials.gov (NCT01377467) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.