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

August 27, 2021 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc
  • France
      • Lyon, France, 69437
        • Hôpital E Herriot
      • Paris, France, 75679
        • Hôpital Cochin
      • Paris, France, 75475
        • Hôpital Lariboisière
  • Germany
      • Berlin, Germany, 12200
        • Hospital Benjamin Franklin
      • Cologne, Germany, 50924
        • Cologne Clinical Centre
      • Heidelberg, Germany, 69120
        • Heildeberg Clinical Centre
  • Netherlands
      • Leiden, Netherlands, 2300
        • Leids Universitair Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
treatment duration: 1 year
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.
Placebo Comparator: 2
treatment duration: 1 year
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: 3
duration treatment: 3 years
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.
Placebo Comparator: 4
treatment duration: 3 years
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Charite University, Berlin, Germany
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: ROLAND D CHAPURLAT, MD PhD, Institut National de la Santé Et de la Recherche Médicale, France
  • Study Director: PHILIPPE ORCEL, MD PhD, Hôpital Lariboisière
  • Study Chair: SOCRATES D PAPAPOULOS, MD PhD, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2007

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 7, 2017

Study Registration Dates

First Submitted

March 8, 2007

First Submitted That Met QC Criteria

March 8, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBM 03-54
  • AFSSAPS 060834

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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