Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
11/07/2014
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 R Eastell

ORCID ID

Contact details

Metabolic Bone Centre
Sorby Wing
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 0114 2714705
r.eastell@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00049829

Protocol/serial number

N0059115932

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases: Osteoporosis

Intervention

Compare zoledronic acid and calcium and vitamin D, with placebo (dummy) and calcium and vitamin D.

Intervention type

Supplement

Phase

Not Specified

Drug names

Zoledronic acid, calcium, vitamin D

Primary outcome measures

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 trial start date

01/07/2002

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Post-menopausal women with osteoporosis.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

7,400 worldwide

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2002

Recruitment end date

30/06/2003

Locations

Countries of recruitment

Germany, United Kingdom, United States of America

Trial participating centre

Metabolic Bone Centre
Sheffield
S5 7AU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Industry

Funder name

Sheffield Teaching Hospitals (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novartis

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

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

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17476007

Publication citations

  1. Results

    Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR, , Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis., N. Engl. J. Med., 2007, 356, 18, 1809-1822, doi: 10.1056/NEJMoa067312.

Additional files

Editorial Notes