Pamidronate for Pain in Sternocostoclavicular Hyperostosis: a double-blind randomized placebo-controlled trial

Recruiting

Conditions: <p>Sternocostoclavicular Hyperostosis</p>

Registration Number: NL-OMON27475

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Adult patients with an established diagnosis of SCCH based on clinical and radiologic features and increased radioactive tracer uptake on 99mTc scan
- Reported maximum pain score of 6/10 or higher
- No treatment with bisphosphonates for the previous 6 months

Exclusion Criteria

- Patients under 18 years of age
- Active pregnancy wish, pregnancy or nursing
- Generalized pain without SCCH related pain
- Bisphosphonate use 6 months before study entry
- Bisphosphonate allergy
- Estimated glomerular filtration rate < 30 ml/min
- Uncontrolled endocrine abnormalities
- Active cancer treatment
- Language barrier, severe co-morbidity, mental disability, poor mobility and other causes preventing attendance for control visits, In case of poor dental hygiene or inadequate dental care, patients will only be enrolled after oral maxillary surgeon consultation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in score of maximal pain on BPI (NRS 0-10) from baseline to 6 months.</p>

Secondary Outcome Measures

Name	Time	Method
<p>- Change in range of motion - Number of patients with mild pain (maximal pain as measured with NRS score in BPI =4) - Number of patients with 50% reduction in maximal pain (NRS score in BPI) - Change in shoulder rating questionnaire and facets of SFA score (among which are ability to dress) - Change in general health, quality of life, fatigue, work activity score, physical activity, and partner burden - Change in standard dose of analgesics (including NSAIDs) possible during course of the study as evidence for efficacy of treatment. - Evaluation of confounding factors for outcome of treatment such as delay in diagnosis and the amount of baseline tracer uptake, pain and range of motion - Evaluation of a possible neuropathic component of the reported pain - Change in biochemical markers of inflammation - Amount of tracer uptake of SCCH lesions on Na18F-PET/CT - Spinal involvement - Cost-effectiveness</p>