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
Scientific
Bridge House Medical Centre
Wassand Close
Three Bridges Road
Crawley
RH10 1LL
United Kingdom
Study information
| Study design | Multicentre randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2004 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bridge House Medical Centre
Crawley
RH10 1LL
United Kingdom
RH10 1LL
United Kingdom
Sponsor information
Roche Products Limited (UK)
Industry
Industry
40 Broadwater Road
Welwyn Garden City
AL7 3AY
United Kingdom
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
