Prevention of bone loss following spinal cord injury
| ISRCTN | ISRCTN46977778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46977778 |
| Protocol serial number | N0209132504 |
| Sponsor | Department of Health |
| Funder | Royal National Orthopaedic Hospital NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 10/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Keen
Scientific
Scientific
RNOHT
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
| Phone | +44 (0)20 8909 5314 |
|---|---|
| richard.keen@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open label randomised controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Changes in Bone Mineral Density and biochemical markers of bone metabolism over time. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 14 |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
RNOHT
Stanmore
HA7 4LP
United Kingdom
HA7 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2011 | Yes | No |
