Clinical Trial: Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

Brief Summary: This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.

Detailed Summary: In open pilot studies, it has been suggested that bisphosphonates may alleviate bone pain and help decrease the surface of osteolytic lesion in patients with fibrous dysplasia of bone (FD). So, in this randomized placebo controlled trial, we test the hypothesis that the bisphosphonate risedronate reduces bone pain in patients with FD (study I, one year duration) and decrease osteolytic lesions (study II, three years duration). Patients will take risedronate during 2 months courses, every 6 months or a matching placebo. Dosage will be : 30mg tablet/day for adults and 5mg tablet x 2,4 according to the age and weight of the child. All participants will receive calcium and vitamin D. All patients with renal phosphate wasting will receive an oral phosphate supplement.
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Current Primary Outcome:

  • Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site. [ Time Frame: one year ]
  • Surface of osteolytic lesions at three years. Radiological improvement. [ Time Frame: Three years ]


Original Primary Outcome:

  • Bone pain at one year
  • Surface of osteolytic lesions at three years


Current Secondary Outcome:

  • Variation of biochemical markers of bone turnover at three years [ Time Frame: three years ]
  • Number of painful sites [ Time Frame: one year ]
  • Improvement in quality of life [ Time Frame: one to three years ]
  • Variation in bone mineral density of the femoral neck at three years [ Time Frame: three years ]


Original Secondary Outcome:

  • Variation of biochemical markers of bone turnover at three years
  • Number of painful sites at one year
  • Improvement in quality of life
  • Variation in bone mineral density of the femoral neck at three years


Information By: Institut National de la Santé Et de la Recherche Médicale, France

Dates:
Date Received: March 8, 2007
Date Started: July 2007
Date Completion: July 2014
Last Updated: December 29, 2011
Last Verified: March 2010