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Effect of denosumab versus zoledronic acid on erosion progression in patients with erosive hand osteoarthritis and osteoporosis: a randomized controlled trial

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Erosive hand osteoarthritis, a condition where the joints at the ends of the fingers develop damage that looks like small pits or cracks in the bone. Participants also have osteoporosis, a condition that makes bones weaker. The trial compares two medicines: denosumab, given as a single shot under the skin (subcutaneous injection), and zoledronic acid, given through an infusion into a vein. The purpose of the study is to see whether denosumab can slow the growth of bone damage compared with zoledronic acid.

People in the study receive their assigned medicine at the start and then are followed for about a year. During this time they return for visits where a special scan called high resolution peripheral quantitative computed tomography—a detailed imaging test that measures the size of bone pits—checks the joints, and they fill out questionnaires about hand pain and function, including the AUSCAN and FIHOA surveys, as well as a simple pain rating called the Pain VAS. These assessments help researchers understand any changes in the bone damage and how the participants feel and use their hands over the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit (v1)

    You arrive at the clinic after joining the study. during this first visit, a series of examinations are performed to record the condition of your hand joints. this includes high‑resolution imaging to measure the size of bone erosions and questionnaires that ask about pain, hand function, and overall disability.

  2. Step 2

    Randomization to treatment group

    After the baseline assessments, you are randomly placed into one of two groups. the assignment is done by the study staff and you will not know which medication you will receive.

  3. Step 3

    Administration of study medication

    If you are assigned to the denosumab group, you receive a single 60 mg subcutaneous injection (injection under the skin) using a pre‑filled syringe.

    If you are assigned to the zoledronic acid group, you receive a single 5 mg infusion (medicine delivered into a vein) over a short period of time.

  4. Step 4

    48‑week follow‑up visit

    Approximately 48 weeks after the baseline visit, you return for a follow‑up appointment. the same imaging technique is used to see whether any hand joints that were not eroded at the start have developed new erosions. you also complete the same questionnaires to report any changes in pain or hand function.

  5. Step 5

    12‑month final visit (v4)

    At 12 months after the baseline visit, you attend the final study visit. high‑resolution imaging is performed again to calculate the change in total erosion volume compared with the baseline scan. you also repeat the questionnaires that measure pain, hand function, and disability. these results are used to determine the overall effect of the medication you received.

Who can join the trial?

7 criteria

  • Men who are at least 50 years old and women who are post‑menopausal, who have osteoporosis and have never taken any medicine for it, and who are being considered for treatment with either denosumab (a medication that helps keep bone strong) or zoledronic acid (another medicine that slows bone loss).
  • People with hand osteoarthritis who have had short, painful swelling episodes in the finger joints, described as “inflammatory” or “erosive” attacks.
  • People whose hand osteoarthritis shows signs of inflammation when examined by a doctor or seen on an ultrasound scan (a safe imaging test that uses sound waves to look at the joints).
  • People whose hand X‑ray (an X‑ray picture of the hand) shows at least one finger joint with the typical “J” or “E” phase appearance that defines erosive hand osteoarthritis.
  • People who are able and willing to sign a written consent form and follow the study’s rules.
  • People whose bone mineral density (BMD) test shows a T‑score of –2.5 or lower at the lumbar spine (lower back), total hip, or femoral neck (the top part of the thigh bone), or a T‑score of –2.0 or lower at these sites plus a previous major osteoporotic fracture (MOF) (a serious break in a bone that is weakened by osteoporosis).
  • People who have signed consent for both taking part in the study and for the use of their personal data.

Who cannot join the trial?

27 criteria

  • You cannot have received IV (intravenous) bisphosphonates at any time, or taken oral bisphosphonate pills in the past 12 months. (Bisphosphonates are medicines that help keep bones strong.)
  • You cannot have been treated with denosumab before. (Denosumab is a medication that reduces bone loss.)
  • You cannot have had cancer (malignancy) within the last five years, except for certain early‑stage skin cancers such as cervical carcinoma in situ, basal cell carcinoma, or localized squamous cell carcinoma.
  • Your blood calcium level must not be too low (hypocalcemia below the normal lower limit). (Hypocalcemia means low calcium in the blood.)
  • Your kidney function, measured by estimated glomerular filtration rate (eGFR), must be at least 35 mL/min/1.73 m² at screening. (eGFR indicates how well the kidneys filter waste.)
  • You must be able to tolerate calcium supplements and vitamin D supplements; severe intolerance excludes you.
  • You must not have any medical reason (contraindication) or serious allergic reaction (hypersensitivity) that makes taking denosumab unsafe.
  • You must not have any medical reason (contraindication) or serious allergic reaction (hypersensitivity) that makes taking zoledronic acid unsafe.
  • You cannot have taken any investigational drug (experimental medication) within the last 4 weeks, or longer if the drug stays in the body for an extended time (5 half‑lives). (Half‑life is the time it takes for half of a drug to leave the body.)
  • The study doctor must consider you a suitable candidate; if the investigator decides you are not a good fit, you cannot join.
  • You cannot have used other bone‑strengthening medicines such as romosozumab, parathyroid hormone (PTH) analogs, or selective estrogen receptor modulators (SERMs).
  • You cannot have a history of an atypical femur fracture (an unusual break in the thigh bone that occurs without major trauma).
  • You must not have an unstable overall health problem (unstable systemic medical condition).
  • Your overactive thyroid (hyperthyroidism) must be under control; uncontrolled hyperthyroidism excludes you.
  • Your underactive thyroid (hypothyroidism) must be under control; uncontrolled hypothyroidism excludes you.
  • You cannot have a history of Addison disease, a condition where the adrenal glands do not produce enough hormones.
  • You cannot have had osteomalacia, a softening of the bones caused by low vitamin D.
  • You cannot have a history of osteonecrosis of the jaw (ONJ), which is death of jaw bone tissue.
  • You cannot have other inflammatory joint diseases such as rheumatoid arthritis, psoriatic arthritis, gout (crystal‑induced arthritis), connective‑tissue disease‑related arthritis, or spondyloarthritis.
  • You cannot have active jaw bone death (active osteonecrosis of the jaw), recent oral surgery that has not healed, a dental infection, or need urgent invasive dental work that would interfere with safe start of the study drug.
  • You cannot have a past history of severe eating disorders (anorexia nervosa, bulimia) or obvious malnutrition.
  • You cannot have had Paget’s disease of bone, a condition that causes abnormal bone remodeling.
  • You cannot have other bone diseases that affect how bone is built or broken down (other bone diseases affecting bone metabolism).
  • Your vitamin D level must not be low (vitamin D deficiency defined as a 25‑OH vitamin D level below 20 ng/mL).
  • Your blood calcium must not be too high (hypercalcemia more than 10 % above the normal upper limit). (Hypercalcemia means high calcium in the blood.)
  • Your liver tests must be within safe limits; elevated transaminases (liver enzymes) or total bilirubin that are 2 times or more above the normal upper limit exclude you.
  • You cannot have had a transplant of any solid organ (such as kidney or liver) or a bone‑marrow transplant.
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Investigated drugs

  • Denosumab

    is a medication given as a subcutaneous injection. In this study it is the test drug, meaning it is being evaluated to see if it can slow down the growth of bone erosions in the hands of people who have both erosive hand osteoarthritis and osteoporosis. The researchers want to find out whether denosumab can protect the joints and reduce damage compared with another treatment.

  • Zoledronic acid

    is a medication that is infused into a vein. In this trial it serves as the comparator, or standard treatment, against which denosumab is measured. Zoledronic acid is already used to treat osteoporosis, and the study is checking if it can also help limit the progression of hand joint erosion in the same patient group.

What is already known about the treatment

  • Denosumab

    This medication is given as a 60 mg subcutaneous injection using a pre‑filled syringe. It is an approved drug that is widely used for osteoporosis and other bone‑loss conditions and is well described in medical literature. It works by attaching to a protein called RANKL, which stops the cells that break down bone from working, thus helping to keep bone strong. Denosumab belongs to the class of monoclonal antibodies and is considered an anti‑resorptive agent.

  • Zoledronic acid

    This drug is administered as a 5 mg infusion, delivered slowly into a vein. It is an approved bisphosphonate used for osteoporosis, Paget disease, and bone complications of cancer, with extensive research supporting its use. It reduces bone loss by interfering with a pathway that osteoclasts need to break down bone, thereby slowing bone breakdown. Zoledronic acid is classified as a bisphosphonate, another type of anti‑resorptive medication.

Investigated diseases

Erosive hand osteoarthritis - It is a form of osteoarthritis that primarily affects the joints of the fingers, causing pain, stiffness, and swelling. Early stages show typical wear‑and‑tear changes, but over time the disease develops small pits and cracks in the bone surface of the joints. These erosive changes replace the normal smooth joint surface and lead to gradual loss of joint shape. As the erosion progresses, the hand may become increasingly stiff and less able to perform everyday tasks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526828-41-00Protocol codeGR-2024-12379704Estimated enrolment150 patientsSponsorAzienda Ospedaliera Universitaria Integrata Verona

sourced from the EU Clinical Trials Register and site verification

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