The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Osteoporosis, Renal Osteodystrophy, Kidney Transplant; Complications
In brief
This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function. The investigators will test whether denosumab safely improves bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) and improves bone strength by high resolution peripheral quantitative computed tomography (HR-pQCT) in the subset of patients recruited at Columbia University Irving Medical Center. These data will inform the development and execution of a larger trial to test if denosumab prevents fractures in kidney transplant recipients.
Key facts
- Study ID
- NCT03960554
- Run by
- Thomas Nickolas, MD MS
- People needed
- 8
- Starts
- 2020-01-16
- Expected to finish
- 2021-12-02
- Last updated by the study team
- 2024-07-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women
- All race-ethnicities
- Age ≥ 18 years
- ≥ 12-months after kidney transplantation (living or deceased donor recipient)
- Stable allograft function over the previous year defined as:
- No rejections
- No more than a 15% decline in Glomerular filtration rate (GFR) over the prior year
- Allograft GFR ≥ 30 mL/minute/1.73 m2 (MDRD or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) per local lab reporting)
- 25OHD ≥ 30 ng/mL (determined at screening visit)
- Serum calcium ≥ 9.0 mg/dL (determined at screening visit)
- T-Score at the spine including and between -1.0 and -3.5 (determined at screening visit)
- Must have had a routine dental exam within 6-months of study recruitment
- Must agree to continue with routine dental exams over the course of the study
- Has not undergone an invasive dental procedure (i.e., tooth extraction, dental implants, oral surgery) within ≤ 3-months of recruitment
- Must agree to referral to metabolic bone disease specialist at the end of the study
- Women of child bearing potential must be willing to use one form of effective contraception over the course of the study
You may not qualify if…
- Allograft GFR < 30 mL/minute/1.73 m2 (MDRD or CKD-EPI per local lab reporting)
- Within 24-months of starting renal replacement therapy
- Prevalent or occult vertebral fractures
- History of post-transplantation non-basal cell carcinoma cancers
- Non-ambulatory
- Malignancy requiring chemotherapy or metastatic to bone
- Non-transplant related metabolic bone diseases that alter bone mineral density, including but not limited to Primary hyperparathyroidism, Paget's, Osteogenesis Imperfecta
- Within one-year of parathyroidectomy
- Untreated hyperthyroidism for 6-months or longer
- Untreated hypothyroidism for 6-months of longer
- Medical diseases (end stage liver, lung or heart, intestinal malabsorption)
- Use within the prior year of bisphosphonates, teriparatide, selective estrogen receptor modulators, testosterone, estrogen, denosumab, abaloparatide, calcitonin, and romosozumab
- Allergy to components within the denosumab preparation or to denosumab
- Weight > 300 pounds
- Parathyroid hormone (PTH) > 450 pg /mL
- Will undergo an invasive dental procedure (i.e., tooth extraction, dental implants, oral surgery) within the next 12-months
- Pregnant
- Planned pregnancy during the course of the study
Where it is running
- Northwestern University, Feinburg School of Medicine — Chicago, Illinois, United States
- NorthShore University HealthSystem — Evanston, Illinois, United States
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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