Denosumab or Zoledronic acid for erosive hand osteoarthritis (EHOA) in patients with osteoporosis a randomized controlled trial (ZODIAC trial)
EU CTIS ID: 2026-526828-41-00
What this study is testing
To demonstrate the reduction in the progression of erosion volume in the denosumab group vs zoledronic acid group
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.