None listed
Conditions
Interventions
Drug : 1. Treatment Group: Denosumab (Obodence® or Prolia®) 60 mg, administered subcutaneously twice at 6-month intervals (Day 1 and Month 6).
2. Control Group: Risedronate 35 mg, administered orally
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged =19 years at the time of informed consent. 2) Diagnosed with a condition requiring glucocorticoid therapy at least 3 months prior to the date of consent. 3) Received systemic prednisolone =450 mg in total (or equivalent glucocorticoid dose) for more than 90 days within the past 6 months. 4) Able to undergo dual-energy X-ray absorptiometry (DXA) assessment of the lumbar spine (minimum of 2 vertebrae) and hip (minimum of 1 site, excluding Ward’s triangle) using DXA, and meeting one of the following: - Postmenopausal women or men =50 years of age: T-score < –1.5 - Premenopausal women or men <50 years of age: Z-score < –3.0 5) Assessed by the treating physician as being an appropriate candidate for either Obodens® (denosumab) 60 mg or risedronate 35 mg once weekly. 6) Voluntarily provides written informed consent after receiving adequate information regarding the purpose and nature of the study.
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to denosumab, risedronate, or any component of either formulation. 2) Pregnant or breastfeeding women, including women not using contraception or planning pregnancy. 3) Judged to be unsuitable for denosumab or bisphosphonate therapy according to approved labeling, including: A) Hypocalcemia, B) Significant renal impairment, defined as creatinine clearance =30 mL/min/1.73 m² calculated using the Cockcroft–Gault equation, C) Esophageal abnormalities that delay emptying, such as stricture or achalasia 4) Prior use of osteoporosis medications, including bisphosphonates, parathyroid hormone (PTH) or PTH analogues, selective estrogen receptor modulators (SERMs), denosumab, or romosozumab: A) Bisphosphonate use within the past 5 years (IV formulations) or 1 year (oral formulations) B) Intravenous fluorides or strontium for osteoporosis within the past 5 years C) PTH or PTH analogues within the past 1 year D) Within 3 months prior to screening, use of any of the following: SERMs, tibolone, anabolic steroids or testosterone, systemic hormone replacement therapy, or calcitonin 5) Considered unsuitable for participation by the investigator. 6) Currently participating in another clinical trial, including post-marketing surveillance for Obodens®. 7) Receiving systemic hormone therapy, such as estrogen alone or combined estrogen-progestogen therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline to Month 12 in lumbar spine bone mineral density (BMD) as measured by DXA, to assess non-inferiority. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent change from baseline to Month 12 in total hip BMD, measured by DXA.;2. Percent change from baseline to Month 12 in femoral neck BMD, measured by DXA.;3. Percent change from baseline to Month 12 in serum bone turnover markers (C-terminal telopeptide of type I collagen [CTX] and procollagen type I N-terminal propeptide [P1NP]), measured at Day 1 (pre-treatment) and Month 12.; Safety Endpoint(Incidence of adverse events (AEs) Discontinuation rate of investigational product (IP) due to AEs Incidence of serious adverse events (SAEs) Incidence of adverse drug reactions (ADRs) Incidence of injection site reactions (e.g., erythema, pruritus, bleeding, pain, swelling) Vital signs (blood pressure, pulse rate) Laboratory test results) | — |
Countries
Korea, Republic of
Contacts
Public ContactChang Hee Suh
Ajou University Hospital
Outcome results
None listed