A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of One-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate, in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000485-13-FI

Enrollment

124

Registered

2006-02-10

Start date

2006-03-28

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteogenesis Imperfecta

Interventions

Product Name: risedronate sodium 2.5mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: risedronic acid CAS Number: 115436-72-1 Current Sponsor code: NE-58095 Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be enrolled in this study, a child must meet the following: a) diagnosed with OI as based on a modified classification scale7,8 (Appendix 1) b) aged 4 through 15 years (= 4 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a) body weight 2 x ULN • thyroid stimulating hormone (TSH) and PTH outside of the normal reference range Note: An iPTH level below the lower limit of the normal range may be associated with calcium supplementation. Therefore, the Investigator and the Medical Monitor will review the patient's personal data and medical history to confirm or refute that the low iPTH level is associated with high calcium supplementation • serum 25(OH) vitamin D 106 µmol/L (1.2 mg/dL) l) current use of anticonvulsant medication m) current use of anticoagulant medication n) participation in another clinical trial within 3 months of enrollment.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to determine the efficacy of risedronate compared to placebo in children = 4 to < 16 years of age with osteogenesis imperfecta (OI) as assessed by % change from Baseline in lumbar spine BMD at Month 12.;Primary end point(s): The primary efficacy endpoint is the percent change from Baseline in lumbar spine BMD at Month 12.;Secondary Objective: a) to evaluate the efficacy of risedronate compared to placebo in children = 4 to < 16 year of age with OI as assessed by: • % change from Baseline in lumbar spine BMD at Month 6 • % change from Baseline in total body BMD • % change from Baseline in total body and lumbar spine BMC • change and % change from Baseline in total body and lumbar spine BMD Z score • % change from Baseline in lumbar spine and total body bone area • incidence and rate of new vertebral fractures • incidence and rate of clinical vertebral and non-vertebral fractures • percent change from Baseline in bone turnover markers • improvement from Baseline in musculoskeletal pain relief • improvement from Baseline in Quality of Life (QOL b) to evaluate the safety and tolerability of risedronate treatment in children = 4 to < 16 year of age with OI as assessed by: • adverse events • laboratory profiles including bone biopsy • change from Baseline in bone age • annualized growth velocity from Baseline	—

Measure

Time frame

Main Objective: The primary objective of this study is to determine the efficacy of risedronate compared to placebo in children = 4 to < 16 years of age with osteogenesis imperfecta (OI) as assessed by % change from Baseline in lumbar spine BMD at Month 12.;Primary end point(s): The primary efficacy endpoint is the percent change from Baseline in lumbar spine BMD at Month 12.;Secondary Objective: a) to evaluate the efficacy of risedronate compared to placebo in children = 4 to < 16 year of age with OI as assessed by: • % change from Baseline in lumbar spine BMD at Month 6 • % change from Baseline in total body BMD • % change from Baseline in total body and lumbar spine BMC • change and % change from Baseline in total body and lumbar spine BMD Z score • % change from Baseline in lumbar spine and total body bone area • incidence and rate of new vertebral fractures • incidence and rate of clinical vertebral and non-vertebral fractures • percent change from Baseline in bone turnover markers • improvement from Baseline in musculoskeletal pain relief • improvement from Baseline in Quality of Life (QOL b) to evaluate the safety and tolerability of risedronate treatment in children = 4 to < 16 year of age with OI as assessed by: • adverse events • laboratory profiles including bone biopsy • change from Baseline in bone age • annualized growth velocity from Baseline

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Countries

Czech Republic, Denmark, Finland, Hungary, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026