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risedronate

Phase 2

Fibrous Dysplasia of Bone | Small molecule | Musculoskeletal |Pulmonx Corporation|Last Updated: Aug 30, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

risedronate · 1 trial · 1 indication

Phase 2 1
NCT00445575Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of BoneFibrous Dysplasia of Bone
COMPLETED80 Analytics
PHASE2COMPLETED
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
Fibrous Dysplasia of BoneUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Variation of biochemical markers of bone turnover at three years
three years
Number of painful sites
one year
Improvement in quality of life
one to three years
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALtreatment duration: 1 year
2PLACEBO_COMPARATORtreatment duration: 1 year
3EXPERIMENTALduration treatment: 3 years
4PLACEBO_COMPARATORtreatment duration: 3 years

Interventions

NameTypeDescription
risedronateDRUGDuring 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.
placeboDRUGplacebo 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.
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Eligibility Criteria

Age Range8 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

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 metabol...

Countries:BelgiumFranceGermanyNetherlands
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Frequently asked questions about risedronate

What is risedronate used for in fibrous dysplasia of bone?

Risedronate is an investigational small molecule being studied for the treatment of fibrous dysplasia of bone, a musculoskeletal condition. It is currently in Phase 2 clinical development and has not been approved for this use. The drug is being evaluated for its effect on bone morbidity in patients with this condition.

What does risedronate target?

Risedronate is a small molecule in the bisphosphonate class, which works by inhibiting bone resorption. It is being studied for its ability to reduce bone morbidity in patients with fibrous dysplasia of bone. The drug's mechanism involves targeting osteoclast activity to help manage the abnormal bone turnover associated with the disease.

Who is developing risedronate?

Risedronate is being developed by Pulmonx Corporation, a company traded on the NASDAQ under the ticker symbol LUNG. The company is conducting clinical research to evaluate the drug's safety and efficacy for the treatment of fibrous dysplasia of bone.

What phase is risedronate in?

Risedronate is in Phase 2 clinical development for the treatment of fibrous dysplasia of bone. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains in the clinical development pipeline.

What clinical trials is risedronate in?

Risedronate has been studied in one completed Phase 2 clinical trial with the identifier NCT00445575. The trial, titled 'Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone,' enrolled 80 participants and was conducted in Belgium, France, Germany, and the Netherlands. The study was randomized, double-blind, and placebo-controlled.

Is risedronate the same as other bisphosphonates?

Risedronate is a bisphosphonate, a class of drugs used to treat bone conditions. It is being studied specifically for fibrous dysplasia of bone. While it shares a mechanism with other bisphosphonates, risedronate is a distinct chemical entity being developed for this indication.