Osteoporosis Clinical Trial
— POSTOPOfficial title:
A Phase 3, Investigator-initiated, Randomized, Open-label Single-center Study of the Effect of Denosumab on the Prevention of Bone Mineral Density Loss After Renal Transplantation
Verified date | July 2014 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | October 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
The key inclusion criteria are: 1. Male or female adult de novo kidney, kidney-pancreas or kidney-islet, or kidney-liver transplant recipients 2. Functioning graft within 28 days after transplantation (creatinine having decreased to <200 micromol/l without the need for dialysis) 3. Being on standard triple immunosuppression including a calcineurin antagonist (cyclosporine or tacrolimus), mycophenolate (MMF or MPA) and steroids, with or without induction treatment with basiliximab or anti-thymocyte globulin Key exclusion criteria are: 1. Age <18 years 2. Rising creatinine after initial drop <200 micromol/l or creatinine >200 micromol/l at baseline 3. Evidence of early acute rejection, either suspected clinically and/or proven by biopsy 4. Presence of severe osteoporosis as evidenced by a T score <-4 at the hip, femoral neck or any of the 4 vertebrae L1 to L4 5. Evidence of severe hyper- or hypoparathyroidism (iPTH >800 ng/l or <10 ng/l) 6. Hypocalcemia (total calcium <1.8 mmol/l) or hypercalcemia (total calcium >2.7 mmol/l) 7. Steroid-free de novo immunosuppression scheme |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Division of Nephrology, University Hospital | Zurich |
Lead Sponsor | Collaborator |
---|---|
Rudolf Wuethrich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lumbar spine bone mineral density (BMD) after one year of treatment | Bone mineral density at 12 months | No | |
Secondary | Occurrence of fractures | BMD changes at the total hip and the femoral neck, changes in body height, and changes in bone mineral metabolism parameters, incidence of fractures, allograft function at one year, occurrence of infections | 1 year | Yes |
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