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

Do bisphosphonates alter the skeletal response to mechanical stimulation in children with osteogenesis imperfecta? - BAMES study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003606-14-GB

Enrollment

Registered

2016-10-17

Start date

2017-01-31

Completion date

Unknown

Last updated

2020-07-20

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

Conditions

Osteogenesis Imperfecta MedDRA version: 19.0 Level: PT Classification code 10031243 Term: Osteogenesis imperfecta System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Actonel 5mg Film Coated Tablets Product Name: Actonel 5mg Film Coated Tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Risedronate Sodium CAS Number: 115436-72-1 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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? 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.	—

Measure

Time frame

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? 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

Measure	Time frame
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.	—

Countries

United Kingdom

Contacts

Public ContactR&D Manager

Sheffield Children's NHS Foundation Trust

wendy.swann@sch.nhs.uk01143053470

Outcome results

None listed

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