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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16800837
Publication citations
-
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.