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

Inclusion Criteria

• 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.

Exclusion Criteria

• • 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 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