Contact information
Type
Scientific
Primary contact
Dr Richard Keen
ORCID ID
Contact details
RNOHT
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
+44 (0)20 8909 5314
richard.keen@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0209132504
Study information
Scientific title
Acronym
Study hypothesis
Do early interventions (drug or mechanical stimulation) reduce the risk of osteoporosis following spinal cord injury?
Please note that as of 16/04/10 this record has been updated and the information obtained from a recent publication of the results (details below). All updates can be found in the relevant field with the above update date.
Ethics approval
Added 16/04/10: Ethical approval was obtained from the Royal National Orthopaedic Hospital NHS Trust ethics committee
Study design
Open label randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Musculoskeletal Diseases: Osteoporosis
Intervention
Patients will be randomly assigned to either
1. Control group,
2. Group receiving zoledronate
3. Group receiving mechanical stimulation (vibration)
and receive the treatment over a 6 month period.
Bone Mineral Density and biochemical markers of bone metabolism will be assessed at the start of the study and at 3 and 6 months after intervention.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Changes in Bone Mineral Density and biochemical markers of bone metabolism over time.
2. Difference between groups
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2003
Overall trial end date
01/08/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients admitted to Royal National Orthopaedic Hospital (RNOH) with a spinal cord injury
Added 16/04/10:
2. Female patients had to be postmenopausal, surgically sterile or willing to practice a medically acceptable form of birth control during the study period and for at least 12 months after study completion
3. All subjects gave written consent to take part in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
14 (added 16/04/10)
Participant exclusion criteria
Added 16/04/10:
1. Pregnant or breastfeeding
2. Previous history of allergic reaction to bisphosphonates
3. Previous history of iritis or uveitis
4. Significant renal impairment or evidence of vitamin D deficiency (serum 25-hydroxyvitamin D <25 nmol/L)
Recruitment start date
01/08/2003
Recruitment end date
01/08/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
RNOHT
Stanmore
HA7 4LP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal National Orthopaedic Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20358358
Publication citations
-
Results
Bubbear JS, Gall A, Middleton FR, Ferguson-Pell M, Swaminathan R, Keen RW, Early treatment with zoledronic acid prevents bone loss at the hip following acute spinal cord injury., Osteoporos Int, 2011, 22, 1, 271-279, doi: 10.1007/s00198-010-1221-6.