Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone - Full Text View

Sponsored by:	Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:	NCT00445575

Purpose

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.

Condition	Intervention	Phase
Fibrous Dysplasia of Bone	Drug: risedronate Drug: placebo	Phase II Phase III

Genetics Home Reference related topics: Melnick-Needles syndrome

Drug Information available for: Risedronate sodium Risedronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	156
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2013

Arms	Assigned Interventions
1: Experimental treatment duration: 1 year	Drug: risedronate
2: Placebo Comparator treatment duration: 1 year	Drug: placebo
3: Experimental duration treatment: 3 years	Drug: risedronate
4: Placebo Comparator treatment duration: 3 years	Drug: placebo

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 30 mg/day in courses over 2 months every 6 months or a matching placebo.All participants will receive calcium and vitamin D. All patients with renal phosphate wasting will receive an oral phosphate supplement.

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445575

Contacts

Contact: ROLAND D CHAPURLAT, MD PhD	33472117481	chapurlat@lyon.inserm.fr
Contact: BEATRICE L BARRAUD, PhD	33144236729	beatrice.barraud@tolbiac.inserm.fr

Locations

Belgium
Cliniques Universitaires Saint Luc	Recruiting
BRUSSELS, Belgium, 1200
Contact: JEAN PIERRE DEVOGELAER, MD 3227645390 devogelaer@ruma.ucl.ac.be
France
Hopital E Herriot	Recruiting
LYON, France, 69437
Contact: ROLAND D CHAPURLAT, MD PhD 33472117481 chapurlat@lyon.inserm.fr
Hopital Lariboisiere	Recruiting
PARIS, France, 75475
Contact: PHILIPPE ORCEL, MD PhD 33149958631 philippe.orcel@lrb.ap-hop.paris.fr
Hopital Cochin	Recruiting
PARIS, France, 75679
Contact: CHRISTIAN ROUX, MD PhD 33158412584
Germany
Hospital Benjamin Franklin	Not yet recruiting
BERLIN, Germany, 12200
Contact: DIETER FELSENBERG, MD PhD 4930844530456 dieter.felsenberg@charite.de
Netherlands
Leids Universitair Medisch Centrum	Not yet recruiting
LEIDEN, Netherlands, 2300
Contact: SOCRATES PAPAPOULOS, MD PhD 31715262490 endocrinologie@lume.nl
United Kingdom
University Hospital of Aberdeen	Not yet recruiting
ABERDEEN, United Kingdom
Contact: DAVID M REID, MD PhD 441224551154 d.m.reid@abdn.ac.uk
Royal National Orthopaedic Hospital	Not yet recruiting
STANMORE, United Kingdom, HA7 4LP
Contact: RICHARD KEEN, MD PhD 442089095289 richard.keen@ucl.ac.uk

Sponsors and Collaborators

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

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	HOPITAL LARIBOISIERE
Study Chair:	PIERRE D DELMAS, MD PhD	Institut National de la Santé Et de la Recherche Médicale, France

More Information

Responsible Party:	Inserm ( Roland Chapurlat )
Study ID Numbers:	RBM 03-54, AFSSAPS 060834
Study First Received:	March 8, 2007
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00445575
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:

fibrous dysplasia of bone
Mac Cune Albright syndrome
bisphosphonates
risedronate

Study placed in the following topic categories:

Calcium, Dietary
Diphosphonates
Fibrous dysplasia of bone
Musculoskeletal Diseases
McCune Albright syndrome
Bone Diseases, Developmental

Osteochondrodysplasias
Fibrous Dysplasia of Bone
Bone Diseases
Risedronic acid
Fibrous dysplasia

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Calcium Channel Blockers
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009