A study to compare zoledronic acid and calcium and vitamin D, with placebo (dummy) and calcium and vitamin D, on the frequency of hip fractures and of new spinal fractures in post-menopausal women with osteoporosis
| ISRCTN | ISRCTN16703536 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16703536 |
| ClinicalTrials.gov number | NCT00049829 |
| Secondary identifying numbers | N0059115932 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 11/07/2014
- 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 R Eastell
Scientific
Scientific
Metabolic Bone Centre
Sorby Wing
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 0114 2714705 |
|---|---|
| r.eastell@sheffield.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | For the UK part of the trial, approved by North Sheffield Research Ethics Committee, reference NS02 1 1247, date of favourable opinion 21/03/02. |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Osteoporosis |
| Intervention | Compare zoledronic acid and calcium and vitamin D, with placebo (dummy) and calcium and vitamin D. |
| Intervention type | Supplement |
| Primary outcome measure | Added 31 July 2008: 1. To assess the incidence of hip fractures in all patients treated with zoledronic acid compared to patients in the placebo group at 3 years 2. To assess the incidence of new vertebal fractures in patients treated with zolendronate acid compared to patients taking placebo at 3 years among patients not taking concomitant therapy for osteoporosis at baseline (stratum 1) |
| Secondary outcome measures | Added 31 July 2008: 1. Percent change in hip BMD as measured by DXA over 3 years 2. Proportion of patients in stratum 1 with new and/or worsening vertebral fractures at 1 year 3. Incidence of all clinical fractures in stratum 1 and 2 over 3 years |
| Overall study start date | 01/07/2002 |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 7,400 worldwide |
| Key inclusion criteria | Post-menopausal women with osteoporosis. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- England
- Germany
- United Kingdom
- United States of America
Study participating centre
Metabolic Bone Centre
Sheffield
S5 7AU
United Kingdom
S5 7AU
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Industry
Sheffield Teaching Hospitals (UK)
No information available
Novartis
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Novartis AG, Novartis International AG
- Location
- Switzerland
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/05/2007 | Yes | No |
