Condition category
Musculoskeletal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
10/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

  1. 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.

Additional files

Editorial Notes