Osteoporosis Clinical Trial
— ProliaKTxOfficial title:
The Effects of 12-months of Denosumab on Bone Density, Quality and Strength in Prevalent Kidney Transplant Recipients
Verified date | April 2022 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 15 |
Est. completion date | December 2, 2021 |
Est. primary completion date | December 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria 1. Men and women 2. All race-ethnicities 3. Age = 18 years 4. = 12-months after kidney transplantation (living or deceased donor recipient) 5. Stable allograft function over the previous year defined as: 1. No rejections 2. No more than a 15% decline in Glomerular filtration rate (GFR) over the prior year 6. Allograft GFR = 30 mL/minute/1.73 m2 (MDRD or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) per local lab reporting) 7. 25OHD = 30 ng/mL (determined at screening visit) 8. Serum calcium = 9.0 mg/dL (determined at screening visit) 9. T-Score at the spine including and between -1.0 and -3.5 (determined at screening visit) 10. Must have had a routine dental exam within 6-months of study recruitment 11. Must agree to continue with routine dental exams over the course of the study 12. Has not undergone an invasive dental procedure (i.e., tooth extraction, dental implants, oral surgery) within = 3-months of recruitment 13. Must agree to referral to metabolic bone disease specialist at the end of the study 14. Women of child bearing potential must be willing to use one form of effective contraception over the course of the study Exclusion Criteria 1. Allograft GFR < 30 mL/minute/1.73 m2 (MDRD or CKD-EPI per local lab reporting) 2. Within 24-months of starting renal replacement therapy 3. Prevalent or occult vertebral fractures 4. History of post-transplantation non-basal cell carcinoma cancers 5. Non-ambulatory 6. Malignancy requiring chemotherapy or metastatic to bone 7. Non-transplant related metabolic bone diseases that alter bone mineral density, including but not limited to Primary hyperparathyroidism, Paget's, Osteogenesis Imperfecta 8. Within one-year of parathyroidectomy 9. Untreated hyperthyroidism for 6-months or longer 10. Untreated hypothyroidism for 6-months of longer 11. Medical diseases (end stage liver, lung or heart, intestinal malabsorption) 12. Use within the prior year of bisphosphonates, teriparatide, selective estrogen receptor modulators, testosterone, estrogen, denosumab, abaloparatide, calcitonin, and romosozumab 13. Allergy to components within the denosumab preparation or to denosumab 14. Weight > 300 pounds 15. Parathyroid hormone (PTH) > 450 pg /mL 16. Will undergo an invasive dental procedure (i.e., tooth extraction, dental implants, oral surgery) within the next 12-months 17. Pregnant 18. Planned pregnancy during the course of the study |
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Thomas Nickolas, MD MS |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral density (BMD) measured by dual energy X-ray absorptiometry (DXA) | BMD will be measured to determine if 1-year of treatment with denosumab changes BMD as measured by DXA. | 12 months | |
Primary | Estimated bone strength measured by high resolution peripheral quantitative computed tomography (HR-pQCT) Imaging | Estimated bone mechanical competence will be measured by HR-pQCT. | 12 months |
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