Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study

Laborértékek

• • Patients with fewer than three lumbar vertebrae that could be evaluated on dual energy x-ray absorptiometry (DXA)
  • Treatment with bisphosphonates in the preceding 2 years
  • Greater than 24 months (>4 injections) of prior treatment with denosumab
  • Women of childbearing potential, who are not currently using birth control, are pregnant, planning to become pregnant, or are breastfeeding. For women of childbearing potential: refusal to use 2 highly effective forms of contraception and to continue this practice for 7 months after last injection of study medication*
  • Men planning to conceive in the next 12 months
  • Unstable systemic medical condition
  • Uncontrolled hyperthyroidism
  • Uncontrolled hypothyroidism
  • History of Addison disease
  • History of osteomalacia
  • History of osteonecrosis of the jaw (ONJ)
  • History of atypical femur fracture
  • History of tooth extraction, jaw surgery, dental implants, or other dental surgery within the prior 6 months
  • History of anorexia nervosa, bulimia (by history or physical) or obvious malnutrition.
  • Invasive dental work(implants/surgery) planned in the next 2 years
  • History of Paget's disease of bone
  • Other bone diseases which affect bone metabolism
  • Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)]
  • Hypercalcemia >10% above upper limit of normal (ULN)
  • Elevated transaminases or total bilirubin ≥ 2.0 x ULN
  • History of any solid organ or bone marrow transplant
  • Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma or localized squamous cell carcinoma of the skin)
  • Hypocalcemia <10% below lower limit of normal (LLN)
  • Estimated glomerular filtration rate < 30 mL/minute/1.73 m\^2
  • Intolerance to calcium supplements, vitamin D supplements
  • Contraindication to, or poorly tolerant of denosumab therapy (including hypersensitivity to the drug)
  • Contraindication to, or poorly tolerant of zoledronic therapy (including hypersensitivity to the drug)
  • Contraindication to, or poorly tolerant of alendronate (including hypersensitivity to the drug and sever gastro-intestinal intolerance to oral bisphosphonates)
  • Recipient of an investigational drug within 4 weeks prior to study drug administration
  • Not a good candidate for study participation in opinion of investigator

• Women and men, age 18 years or older and able to provide informed consent (IC)
• ≥ 3 months of glucocorticoid use at > 7.5 mg /day (prednisone equivalent dose) and anticipated to remain on glucocorticoids for at least six months
• A baseline BMD T-score of ≤ -2.0 at the lumbar spine, total hip, or femoral neck; OR
• A BMD T-score ≤ -1.0 at the lumbar spine, total hip, or femoral neck and a history of an osteoporotic fracture.