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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Lfnms Udltoquqjltw Mcpffex Cgxevrq (fcpod	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.09.2020

Trial locations

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).

Investigated diseases:

Bone hypertrophy

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 ID:

2023-510309-16-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?