CompletedPhase 2/3

Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

Belgium, France, Germany80 participantsStarted 2007-07-22

Plain-language 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.

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site.

Timeframe: one year

Surface of osteolytic lesions at three years. Radiological improvement.

Timeframe: Three years

Trial details

NCT IDNCT00445575

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

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Fibrous Dysplasia of Bone trials

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.