Randomised, open-label, multi-centre study designed to reflect routine clinical care in order to assess persistence on treatment in women with postmenopausal osteoporosis receiving once-monthly ibandronate with a patient support programme versus once-weekly alendronate

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Alun Cooper
Scientific

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

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PERSIST
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Ibandronate, alendronate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/06/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1000
Key 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
Key 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
Date of first enrolment	01/12/2004
Date of final enrolment	30/06/2005

Bridge House Medical Centre

Crawley
RH10 1LL
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	01/08/2006		Yes	No