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

ISRCTN ISRCTN79315974
DOI https://doi.org/10.1186/ISRCTN79315974
Secondary identifying numbers MA18160
Submission date
25/07/2005
Registration date
25/08/2005
Last edited
16/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alun Cooper
Scientific

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

Study information

Study designMulticentre randomised open label active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymPERSIST
Study objectivesMonthly 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) studiedPostmenopausal Osteoporosis
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ibandronate, alendronate
Primary outcome measurePersistence (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 measures1. 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 study start date01/12/2004
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants1000
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2004
Date of final enrolment30/06/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Bridge House Medical Centre
Crawley
RH10 1LL
United Kingdom

Sponsor information

Roche Products Limited (UK)
Industry

40 Broadwater Road
Welwyn Garden City
AL7 3AY
United Kingdom

ROR logo "ROR" https://ror.org/024tgbv41

Funders

Funder type

Industry

Roche Products Limited (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2006 Yes No