Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Osteogenesis Imperfecta

Treatments: Drug: Placebo; Drug: risedronate sodium (Actonel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00106028

2003100

HMR4003I/3001

Details and patient eligibility

About

Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.

Enrollment: 143 patients

Sex: All

Ages: 4 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OI diagnosis
• increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.

Exclusion criteria

• Any bisphosphonate use within one year of enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

143 participants in 2 patient groups, including a placebo group

Placebo Daily

Placebo Comparator group

Description:

placebo tablet, once a day for one year then for two years open label risedronate

Treatment:

Drug: Placebo

Risedronate Daily

Experimental group

Description:

risedronate tablet, once a day for one year then for two years open label risedronate once a day

Treatment:

Drug: risedronate sodium (Actonel)