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

Primary Purpose

Fibrous Dysplasia of Bone

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
risedronate
placebo
risedronate
placebo
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrous Dysplasia of Bone focused on measuring fibrous dysplasia of bone, Mac Cune Albright syndrome, bisphosphonates, risedronate

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint Luc
  • Hopital E Herriot
  • Hopital Lariboisiere
  • Hopital Cochin
  • Hospital Benjamin Franklin
  • Cologne Clinical Centre
  • Heildeberg Clinical Centre
  • Leids Universitair Medisch Centrum

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

treatment duration: 1 year

treatment duration: 1 year

duration treatment: 3 years

treatment duration: 3 years

Outcomes

Primary Outcome Measures

Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site.
Surface of osteolytic lesions at three years. Radiological improvement.

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2007
Last Updated
August 27, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00445575
Brief Title
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
Acronym
PROFIDYS
Official Title
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 22, 2007 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrous Dysplasia of Bone
Keywords
fibrous dysplasia of bone, Mac Cune Albright syndrome, bisphosphonates, risedronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
treatment duration: 1 year
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
treatment duration: 1 year
Arm Title
3
Arm Type
Experimental
Arm Description
duration treatment: 3 years
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
treatment duration: 3 years
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site.
Time Frame
one year
Title
Surface of osteolytic lesions at three years. Radiological improvement.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Variation of biochemical markers of bone turnover at three years
Time Frame
three years
Title
Number of painful sites
Time Frame
one year
Title
Improvement in quality of life
Time Frame
one to three years
Title
Variation in bone mineral density of the femoral neck at three years
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROLAND D CHAPURLAT, MD PhD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PHILIPPE ORCEL, MD PhD
Organizational Affiliation
HOPITAL LARIBOISIERE
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
SOCRATES D PAPAPOULOS, MD PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Hopital E Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Hospital Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Cologne Clinical Centre
City
Cologne
ZIP/Postal Code
50924
Country
Germany
Facility Name
Heildeberg Clinical Centre
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2300
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.dysplasie-fibreuse-des-os.info/fr/accueil.html
Description
Related Info

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Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

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