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

• Register: EUCTR
• Last refreshed on: 20 July 2020
• Main ID: EUCTR2016-003606-14-GB
• Date of registration: 17/10/2016
• Prospective Registration: Yes
• Primary sponsor: Sheffield Children's NHS Foundation Trust
• Public title: Brittle bones - do they react normally after treatment with bisphosphonates?
• Scientific title: Do bisphosphonates alter the skeletal response to mechanical stimulation in children with osteogenesis imperfecta? - BAMES study
• Date of first enrolment: 31/01/2017
• Target sample size: 15
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003606-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Contacts

• Name: R&D Manager
• Affiliation: Sheffield Children's NHS Foundation Trust

• Name: R&D Manager
• Affiliation: Sheffield Children's NHS Foundation Trust

Key inclusion & exclusion 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:
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




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Actonel Once a Week 35 mg film-coated tablets
Product Name: Actonel Once a Week 35 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Risedronate Sodium
CAS Number: 115436-72-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 35-

Primary Outcome(s)

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 Objective: Does Osteogenesis Imperfecta bone respond to mechanical stimulation at all?
And if so, how?

Main Objective: Do bisphosphonates alter the skeletal response to mechanical stimulation in children with osteogenesis imperfecta?

Secondary Outcome(s)

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.

Secondary ID(s)

SCH-2013

Source(s) of Monetary Support

Chief Investigators Discretionary Funding Account

SPARKS charity

Ethics review

Status: Approved
Approval date: 31/01/2017
Contact: