Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief 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


Options:
A: 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
B: Inclusion Criteria:

* Renal transplant recipients between 12 and 48 months after transplantation with a stable renal function during the past 3 months.
* Vitamine D insufficiency defined as a concentration of 25OHD lower than 30 ng/ml.
* Patient between 18 and 75 years old
* Patient capable of understanding the advantages and the risks of the study.
* Affiliated with social security health insurance
* Written informed consent

Exclusion Criteria:

* Calcaemia \> 2,7 mmol/l
* Phosphataemia \> 1,5 mmol/l
* Serum creatinine \> 250 µmol/l
* Treatment by an active form of the vitamin D not being able to be interrupted
* Transplant of an organ other than the kidney
* Type I or type II diabetes mellitus
* Past medical history of granulomatosis or active granulomatosis
* Primary hyperoxaluria
* Malabsorption proved by the liposoluble vitamins
* Simultaneous participation in another therapeutic essay
* Patients presenting a drug addiction or a psychiatric disorder
* Pregnant or breast-feeding women
* Vitamin D hyper sensibility
C: Inclusion Criteria:

* age \> 18
* deceased donor kidney transplant recipients
* only kidney transplant recipients
* vitamin D deficiency defined as 25 (OH)D \< 50nmol/l

Exclusion Criteria:

* re-transplantation for the second time if the patient is highly immunized and therefore included in the aphaeresis program
* re-transplantation for the third or further time
* significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mucoviscidosis, Zollinger-Ellison-syndrome
* history of inflammatory bowel disease: Crohn's disease, ulcerative colitis
* previous gastrectomy, small bowel or large bowel resection, intestinal bypass surgery
* severe liver disease: cirrhosis
* HIV positive
D: Inclusion Criteria:

* Patients with a renal graft having been transplanted within the previous 8 years and being at least 3 months post transplantation, or, patients scheduled to undergo transplantation from a living organ donor within the upcoming 3 months
* Venous serum bicarbonate concentration \< 24 mmol/L at time of baseline determination
* Renal transplant function with a calculated glomerular filtration rate (GFR) greater or equal 30 ml/min according to the Cockcroft-Gault formula
* Immunosuppressive therapy including a calcineurin inhibitor (cyclosporine A or tacrolimus)
* Age 20 through 65 years of either sex
* Written informed consent for study participation

Exclusion Criteria:

* Acute rejection episode requiring specific therapy within 4 weeks before study inclusion
* Severe impairment in general health and/or physical handicaps (malignant neoplasia, catabolic state, acute systemic infection requiring therapy)
* Mental illness, psychiatric disorder
* Tetracycline intolerance
* Planned or "overt" pregnancy

Answer: A