Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A P… (NCT04177940) | Clinical Trial Compass
CompletedPhase 4
Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study
United States45 participantsStarted 2020-08-17
Plain-language summary
Investigators will test the hypothesis that an increase in bone turnover markers (e.g. carboxy-terminal collagen crosslinks (CTX) and P1NP) in patients currently taking chronic glucocorticoids will be attenuated more in those who switch from denosumab to "late" zoledronic acid (9 months after last denosumab dose) compared to participants randomized to "early" zoledronic acid (6 months after last denosumab dose) or weekly alendronate (6 months after last denosumab dose).
Who can participate
Age range18 Years
SexALL
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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 nervo…
What they're measuring
1
Absolute Difference in the Log-transformed CTX Values Between V4 vs. V6
Timeframe: from randomization (V4) through 6 months post randomization (V6)