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Study of Pamidronate for Pain Relief in Patients with Sternocostoclavicular Hyperostosis (SCCH)

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What is this trial about?

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

This study focuses on patients with Sternocostoclavicular hyperostosis, a rare condition that causes inflammation and abnormal bone growth in the chest wall, particularly affecting the breastbone, ribs, and collarbone area. The research evaluates the effectiveness of pamidronate, a medication given through intravenous infusion, in reducing pain associated with this condition.

The study aims to determine if pamidronate treatment given every three months can significantly decrease pain in patients compared to placebo. During the study, participants will receive either pamidronate or a sodium chloride solution (placebo) through an intravenous infusion. The maximum treatment period is 12 months.

The treatment involves receiving infusions at regular intervals, with the medication dose not exceeding 30 milligrams per day or 90 milligrams in total. Patients' pain levels will be monitored throughout the study period using standardized pain assessment tools. The study will also track changes in movement ability, general health, and daily activities to understand how the treatment affects patients' quality of life.

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

    Initial pain assessment

    Your pain level will be measured using a Brief Pain Inventory (BPI) scale from 0 to 10

    Medical imaging will be performed to confirm active disease at pain sites

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either pamidronate or placebo treatment

    Neither you nor your doctor will know which treatment you are receiving

  3. Step 3

    Treatment administration

    You will receive treatment through an intravenous infusion (directly into your vein)

    Treatments will be given every 3 months

    The treatment period will last for 6 months in total

  4. Step 4

    Regular assessments

    Your pain levels will be monitored regularly

    Your ability to move will be evaluated

    Your general health and quality of life will be assessed

    Your medication usage will be tracked

    Blood tests will be performed to check inflammation markers

  5. Step 5

    Final evaluation

    After 6 months, your pain levels will be measured again

    Your movement range will be assessed

    The effectiveness of the treatment will be evaluated

    Medical imaging will be performed to check disease activity

Who can join the trial?

6 criteria

  • Patient must be experiencing pain at lesion sites with a severity of at least 6 out of 10 on the pain scale (where 10 is the worst pain)
  • Patient must have active signs of inflammation that can be seen on medical imaging tests (such as X-rays, MRI, or bone scans) at the affected areas
  • Patient must not have received bisphosphonate treatment (medications used to treat bone conditions) in the past 6 months
  • Patient can be either male or female
  • Patient must be an adolescent or adult (from age 12 and above)
  • Patient must have inflammation in the chest bone area (sternum) or a condition called sternocostoclavicular hyperostosis (increased bone growth in the upper chest area)

Who cannot join the trial?

15 criteria

  • Age below 12 years or above 65 years
  • Known allergies or hypersensitivity to pamidronate (the study medication) or similar drugs
  • Presence of active dental problems or upcoming dental procedures
  • Severe kidney problems or abnormal kidney function
  • Current pregnancy or breastfeeding
  • Recent surgery of the jaw or dental area (within last 6 months)
  • Low blood calcium levels (hypocalcemia)
  • Active treatment with other medications that affect bone metabolism
  • Inability to follow study procedures or attend scheduled visits
  • Participation in other clinical trials within the last 30 days
  • Severe heart, liver, or blood disorders
  • History of cancer within the past 5 years
  • Current use of medications that might interact with the study drug
  • Inability to provide informed consent
  • Conditions that might affect pain assessment reliability
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Investigated drugs

Pamidronate is a medication that belongs to a group of drugs called bisphosphonates. It works by slowing down bone loss and reducing the activity of cells that break down bone tissue. This medication is commonly used to treat conditions that affect bone health and can help reduce bone pain. In this trial, it is being studied for its effectiveness in reducing pain in patients with sternocostoclavicular hyperostosis (a rare condition that causes inflammation and overgrowth of bone tissue in the chest area).

What is already known about the treatment

Pamidronate – A bisphosphonate medication administered through intravenous infusion, primarily used to treat bone-related conditions and manage bone pain. This drug works by inhibiting bone resorption and decreasing the activity of osteoclasts (bone cells that break down bone tissue), making it effective for conditions involving bone inflammation such as sternocostoclavicular hyperostosis and chronic non-bacterial osteomyelitis (CNO). Pamidronate belongs to the class of medications known as bone resorption inhibitors and has been well-documented in medical literature for its ability to reduce bone pain and improve bone density. The medication is typically administered in cycles every three months in a hospital or clinic setting under medical supervision.

Investigated diseases

  • Inflammation of sternal region

    A condition characterized by inflammation of the sternum (breastbone) and surrounding tissues. The inflammation can cause pain and tenderness in the chest area, particularly around the breastbone. This condition can develop gradually and may affect the joints where the ribs connect to the sternum.

  • Sternocostoclavicular hyperostosis

    A rare bone condition that causes abnormal bone growth and inflammation in the sternum, upper ribs, and collarbones. The condition typically causes progressive thickening of these bones and surrounding tissue. It can result in chest pain and reduced mobility in the shoulder area. The condition often develops slowly over time and can affect one or both sides of the upper chest area.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510309-16-00Estimated enrolment70 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

sourced from the EU Clinical Trials Register and site verification

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