Brittle bones - do they react normally after treatment with bisphosphonates?

Phase 1

• Conditions: Osteogenesis Imperfecta; MedDRA version: 19.0Level: PTClassification code 10031243Term: Osteogenesis imperfectaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-003606-14-GB
• Lead Sponsor: Sheffield Children's NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-17
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Age 4-16 years
Able to speak fluent English
Diagnosed with osteogenesis imperfecta
Able to stand
Not treated with bisphosphonates
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Presence of other chronic illnesses
Balance problems
Recent fracture (in the last 6 months)
Recent (last 12 months) or current treatment likely to affect bone – this does not include inhaled or intermittent oral therapy with steroids for asthma
Involvement in another interventional research project

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Do bisphosphonates alter the skeletal response to mechanical stimulation in children with osteogenesis imperfecta?;Secondary Objective: Does Osteogenesis Imperfecta bone respond to mechanical stimulation at all?<br>And if so, how?;Primary end point(s): Change in P1NP in response to 1 week of whole body vibration, following 6 weeks of risedronate at a dose of 1mg/kg/week.;Timepoint(s) of evaluation of this end point: 15 to 18 months for total study duration; each individual patient will be studied over a period of 99 days.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in ALP and CTx in response to 1 week of whole body vibration, following 6 weeks of risedronate at a dose of 1mg/kg/week.;Timepoint(s) of evaluation of this end point: As for primary end-point; 15 to 18 months for total study duration; each individual patient will be studied over a period of 99 days.