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

Completed · Phase 4

Conditions studied: Osteoporosis

In brief

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).

Key facts

Study ID

NCT04177940

Run by

University of Alabama at Birmingham

People needed

45

Starts

2020-08-17

Expected to finish

2025-01-14

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• • 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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