Condition category
Cancer
Date applied
30/06/2010
Date assigned
30/06/2010
Last edited
09/09/2015
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

Prof Robert E Coleman

ORCID ID

Contact details

Department of Clinical Oncology
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
+44 114 226 5213
r.e.coleman@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1195

Study information

Scientific title

Effect of an annual infusion of zoledronate on bone mineral density in patients on long term follow up with cancer remission and anti-neoplastic treatment induced bone loss study

Acronym

Annual zoledronate

Study hypothesis

No previous study has been carried out in men and women in long term remission from cancers such as breast cancer, lymphoma and testicular cancer with treatment induced osteopenia or osteoporosis. The aim of the proposed study was to determine whether in such patients, an annual 4 mg dose of intraveous (IV) zoledronic acid results in significant increase in bone mineral density (BMD) measured one year later. Further more to assess whether any benefit obtained in such patients is maintained.

Ethics approval

South Sheffield LREC approved on the 3rd September 2001 (ref: SSLREC/01/113)

Study design

Multicentre non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: Breast, Colon, Lymphoma (Hodgkin's), Lymphoma (non-Hodgkin's), Testis, Melanoma

Intervention

Zoledronic acid 4 mg intravenously once a year. DEXA scans at baseline, 1, and 2 years of lumbar spine and hip

Study entry: other

Intervention type

Drug

Phase

Not Applicable

Drug names

Zoledronic acid

Primary outcome measures

Change in BMD at hip and spine, measured by DEXA scan at 1 and 2 years

Secondary outcome measures

Improvement in bone resorption marker levels, measured at 0, 6, 12, 18, 24, 36, 48 and 60 months.

Overall trial start date

01/09/2001

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven malignant disease
2. Complete response of primary disease to chemotherapy and/or radiotherapy and no evidence of metastases
3. Osteoporosis or osteopaenia (as defined by World Health Organization [WHO] criteria) at screening dual energy x-ray absorptiometry (DEXA) scan
4. Confirmation of post-menopausal status (female patients) as determined by serum follicle-stimulating hormone (FSH) greater than 15 mU/ml and oestradiol levels of less than 30 pg/ml
5. Aged 18 years or above
6. Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
7. No previous treatment with bisphosphonate
8. No treatment with anabolic steroids, fluoride, calcitonin or vitamin D within the last six months
9. No change in endocrine therapy in last three months
10. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
11. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 80

Participant exclusion criteria

1. Abnormal renal function (serum creatinine level greater than 130 µM/L or greater than 1.5 mg/dL)
2. Pregnancy/lactation (female patients)
3. Other disorders of bone metabolism e.g., Paget's disease, hyperparathyroidism, renal osteodystrophy

Recruitment start date

01/09/2001

Recruitment end date

01/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Clinical Oncology
Sheffield
S10 2SJ
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
+44 114 22 21448
R.J.Hudson@sheffield.ac.uk

Sponsor type

University/education

Website

http://www.sheffield.ac.uk/

Funders

Funder type

Charity

Funder name

Weston Park Cancer Appeal (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A follow up long term follow-up publication is planned for late 2015/early 2016.

Intention to publish date

01/02/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results 2007: http://www.ncbi.nlm.nih.gov/pubmed/17875770

Publication citations

Additional files

Editorial Notes