2026-526828-41-00招募中2 期
Denosumab or Zoledronic acid for erosive hand osteoarthritis (EHOA) in patients with osteoporosis a randomized controlled trial (ZODIAC trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The primary endpoint is the difference in mean change of total erosion volume (mm3) of target joints (II, III, IV, V distal and proximal interphalangeal joints and II, III, IV, V metacarpal phalangeal joints) assessed with high resolution peripheral quantitative computed tomography (HRpQCT) using standardized approach between baseline (V1) and 12 months after baseline (V4)
研究概览
简要总结
To demonstrate the reduction in the progression of erosion volume in the denosumab group vs zoledronic acid group
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men ≥50 years of age and post-menopausal women with osteoporosis naïve to any anti-osteoporosis medication candidate to treatment to either denosumab of zoledronic acid
- •Subjects with hand OA having suffered from transient inflammatory attacks of the interphalangeal finger joints characteristic for what has been termed ‘inflammatory’ or ‘erosive’ hand OA.
- •Subjects with hand OA showing inflammatory signs, either clinically or ultrasonographically, of the interphalangeal finger joints
- •Subjects with hand OA in which at least 1 interphalangeal finger joint has the typical appearance on the X-rays of a ‘J’ or ‘E’ phase joint as defined by the criteria mentioned above
- •Able and willing to give written informed consent and to comply with the requirements of the study protocol.
- •A baseline BMD T-score of ≤ -2.5 at the lumbar spine, total hip, or femoral neck or baseline T-score of ≤-2.0 at the lumbar spine, total hip, or femoral neck + a prevalent MOF fracture
- •Signed informed consent for participation in the study and for the processing of personal data
排除标准
- •No past IV bisphosphonates at any time, or any oral bisphosphonate use within 12 months before screening
- •No past treatment with denosumab
- •Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma or localized squamous cell carcinoma of the skin)
- •Hypocalcemia below lower limit of normal (LLN)
- •Estimated glomerular filtration rate < 35 mL/minute/1.73 m^2 at the time of screening/randomization
- •Intolerance to calcium supplements, vitamin D supplements
- •Contraindication to, or poorly tolerant of denoosumab therapy (including hypersensitivity to the drug and any excipients)
- •Contraindication to, or poorly tolerant of zoledronic acid therapy (including hypersensitivity to the drug and any excipients)
- •Recipient of an investigational drug within 4 weeks prior to study drug administration or within 5 half-lives of the investigational drug, whichever is longer
- •Not a good candidate for study participation in opinion of investigator
- •No past treatment with other anti-osteoporosis medications (romosozumab, PTH analogs, SERMs etc.)
- •History of atypical femur fracture
- •Unstable systemic medical condition
- •Uncontrolled hyperthyroidism
- •Uncontrolled hypothyroidism
- •History of Addison disease
- •History of osteomalacia
- •History of osteonecrosis of the jaw (ONJ)
- •History or presence of inflammatory or erosive arthritides other than erosive hand osteoarthritis (EHOA), including rheumatoid arthritis, psoriatic arthritis, crystal-induced arthritis, connective tissue disease-related arthritis, and spondyloarthritis
- •Active osteonecrosis of the jaw (ONJ), unhealed oral surgery, active dental infection, or planned urgent invasive dental procedure that is considered incompatible with safe initiation of study treatment
- •History of anorexia nervosa, bulimia (by history or physical) or obvious malnutrition
- •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
研究组 & 干预措施
Obodence 60 mg solution for injection in pre-filled syringe
Test
干预措施: Obodence 60 mg solution for injection in pre-filled syringe (Drug)
Aclasta 5 mg solution for infusion
Comparator
干预措施: Aclasta 5 mg solution for infusion (Drug)
结局指标
主要结局
The primary endpoint is the difference in mean change of total erosion volume (mm3) of target joints (II, III, IV, V distal and proximal interphalangeal joints and II, III, IV, V metacarpal phalangeal joints) assessed with high resolution peripheral quantitative computed tomography (HRpQCT) using standardized approach between baseline (V1) and 12 months after baseline (V4)
The primary endpoint is the difference in mean change of total erosion volume (mm3) of target joints (II, III, IV, V distal and proximal interphalangeal joints and II, III, IV, V metacarpal phalangeal joints) assessed with high resolution peripheral quantitative computed tomography (HRpQCT) using standardized approach between baseline (V1) and 12 months after baseline (V4)
次要结局
- The secondary endpoint will be the number and proportion of interphalangeal joints progressing from non‑erosive disease, defined as S/J phase at baseline, to erosive disease, defined as E phase at 48 weeks.
- The change from baseline to Month 12 in patient‑reported and functional outcomes, including AUSCAN (AUStralian CANadian Osteoarthritis Hand Index), FIHOA (Functional Index of Hand Osteoarthritis), and Pain VAS, reflecting pain, hand function, and disability from the patient perspective.
研究者
Giovanni Adami
Scientific
Azienda Ospedaliera Universitaria Integrata Verona
研究点 (2)
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