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 (NCT)	NCT00049829
Protocol serial number	N0059115932
Sponsor	Department of Health (UK)
Funders	Sheffield Teaching Hospitals (UK), Novartis

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr R Eastell
Scientific

Metabolic Bone Centre
Sorby Wing
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom

Phone	+44 0114 2714705
Email	r.eastell@sheffield.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	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
Completion date	30/06/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	7400
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

Metabolic Bone Centre

Sheffield
S5 7AU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/05/2007		Yes	No