Prevention of bone loss following spinal cord injury

ISRCTN	ISRCTN46977778
DOI	https://doi.org/10.1186/ISRCTN46977778
Secondary identifying numbers	N0209132504

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Richard Keen
Scientific

RNOHT
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom

Phone	+44 (0)20 8909 5314
Email	richard.keen@ucl.ac.uk

Study design	Open label randomised controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title
Study objectives	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(s)	Added 16/04/10: Ethical approval was obtained from the Royal National Orthopaedic Hospital NHS Trust ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/08/2003
Completion date	01/08/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	14 (added 16/04/10)
Key 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
Key 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)
Date of first enrolment	01/08/2003
Date of final enrolment	01/08/2005

RNOHT

Stanmore
HA7 4LP
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Hospital/treatment centre

Royal National Orthopaedic Hospital NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No