Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone (PROFIDYS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00445575
First received: March 8, 2007
Last updated: December 29, 2011
Last verified: March 2010

March 8, 2007
December 29, 2011
July 2007
July 2013   (final data collection date for primary outcome measure)
  • Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Surface of osteolytic lesions at three years. Radiological improvement. [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • Bone pain at one year
  • Surface of osteolytic lesions at three years
Complete list of historical versions of study NCT00445575 on ClinicalTrials.gov Archive Site
  • Variation of biochemical markers of bone turnover at three years [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Number of painful sites [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Improvement in quality of life [ Time Frame: one to three years ] [ Designated as safety issue: No ]
  • Variation in bone mineral density of the femoral neck at three years [ Time Frame: three years ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibrous Dysplasia of Bone
  • Drug: risedronate
    During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
  • Drug: placebo
    placebo and risedronate have exactly the same aspect. During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
  • Experimental: 1
    treatment duration: 1 year
    Intervention: Drug: risedronate
  • Placebo Comparator: 2
    treatment duration: 1 year
    Intervention: Drug: placebo
  • Experimental: 3
    duration treatment: 3 years
    Intervention: Drug: risedronate
  • Placebo Comparator: 4
    treatment duration: 3 years
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
156
July 2014
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Study I: patients with FD, with bone pain intensity above 3 on visual analogical scale from 0 to 10
  • Study II: patients with FD with at least one osteolytic lesion and no current bone pain

Exclusion Criteria:

  • patients < 8 years old
  • other diseases affecting bone metabolism
  • patients with malignant diseases or other conditions likely to reduce their life expectancy to less than 3 years
  • patients with history of significant upper gastrointestinal disorders
  • renal failure (creatinine clearance < 25 ml/mn)
  • severe liver disease
  • history of iritis or uveitis
  • rickets or osteomalacia
  • allergy to bisphosphonates
  • pregnancy or lactation
  • prior treatment with a bisphosphonate
  • laboratory abnormalities that may be considered as clinically significant by trial physicians
Both
8 Years and older
No
Contact: ROLAND D CHAPURLAT, MD PhD 33472117481 roland.chapurlat@chu-lyon.fr
Contact: CECILE L PELTEKIAN, PhD 33144236341 cecile.peltekian@inserm.fr
Belgium,   Germany,   France,   Netherlands
 
NCT00445575
RBM 03-54, AFSSAPS 060834
Yes
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • Charite University, Berlin, Germany
Principal Investigator: ROLAND D CHAPURLAT, MD PhD Institut National de la Santé Et de la Recherche Médicale, France
Study Director: PHILIPPE ORCEL, MD PhD HOPITAL LARIBOISIERE
Study Chair: SOCRATES D PAPAPOULOS, MD PhD Leiden University Medical Center
Institut National de la Santé Et de la Recherche Médicale, France
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP