Condition category
Musculoskeletal Diseases
Date applied
25/07/2005
Date assigned
25/08/2005
Last edited
16/09/2009
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 Alun Cooper

ORCID ID

Contact details

Bridge House Medical Centre
Wassand Close
Three Bridges Road
Crawley
RH10 1LL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MA18160

Study information

Scientific title

Acronym

PERSIST

Study hypothesis

Monthly ibandronate with a patient support programme increases persistence on treatment compared to weekly alendronate. This will be tested using survival analysis techniques.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Postmenopausal Osteoporosis

Intervention

The once-monthly single tablet of ibandronate 150 mg (study drug) will be provided for those patients randomised to group A together with a patient support programme, and the comparator alendronate 70 mg weekly will be provided for those patients randomised to group B

Intervention type

Drug

Phase

Not Specified

Drug names

Ibandronate, alendronate

Primary outcome measures

Persistence (time on therapy) of patients receiving once-monthly dosing of ibandronate with patient support programme versus patients receiving once-weekly alendronate. Persistence with therapy will be measured on the basis of the number of months of study drug dispensed to the patient by the pharmacy i.e. prescription refills.

Secondary outcome measures

1. All patients that withdraw from the study must have the reason for discontinuation recorded
2. All adverse events will be reported as part of general safety assessments

Overall trial start date

01/12/2004

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with postmenopausal osteoporosis diagnosed according to clinical judgement of the treating physician
2. Patients who, in the opinion of the investigator, are able to comply with the protocol requirements and are independent (self-caring)
3. Patients who have signed informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1000

Participant exclusion criteria

1. Patients who were previously exposed to or are currently on a biphosphonate
2. Unlikely to complete the entire 6-month study period due to significant medical condition
3. Inability to stand or sit upright for at least 60 minutes
4. Abnormalities of the oesophagus that delay oesophageal emptying, such as achalasia and stricture
5. Hypersensitivity to biphosphonates
6. Administration of any investigational drug within 30 days preceeding the first dose of study drug

Recruitment start date

01/12/2004

Recruitment end date

30/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bridge House Medical Centre
Crawley
RH10 1LL
United Kingdom

Sponsor information

Organisation

Roche Products Limited (UK)

Sponsor details

40 Broadwater Road
Welwyn Garden City
AL7 3AY
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Roche Products Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16800837

Publication citations

  1. Results

    Cooper A, Drake J, Brankin E, , Treatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study., Int. J. Clin. Pract., 2006, 60, 8, 896-905, doi: 10.1111/j.1742-1241.2006.01059.x.

Additional files

Editorial Notes