Open-label, multicentre study to assess the persistence on treatment in women with postmenopausal osteoporosis receiving once-monthly ibandronic acid with either a patient support programme (PSP) or bone turnover marker monitoring (BM)

ISRCTN	ISRCTN64773345
DOI	https://doi.org/10.1186/ISRCTN64773345
Secondary identifying numbers	ML 18373

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Patricia Campbell
Scientific

Roche Products Ltd
40 Broadwater road
Welwyn Garden City
AL7 3AY
United Kingdom

Phone	+44 (0)1707 367862

Study design	Multicentre randomised open label controlled trial
Primary study design	Interventional
Secondary study design	Multi-centre
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	Back up study
Study objectives	The aim of the study is to compare the persistence rates of patients treated with once-monthly ibandronic acid who receive feedback on the change in their bone turnover marker with patients who receive once-monthly ibandronic acid and a patient support programme.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Osteoporosis
Intervention	Patients randomised to: 1. Treatment with once-monthly ibandronic acid and feedback on the change in their bone turnover marker 2. Treatment with once-monthly ibandronic acid and a patient support programme
Intervention type	Other
Primary outcome measure	To assess persistence on treatment (time on therapy) of once-monthly ibandronic acid when patients are randomised to either ibandronic acid with patient support programme (PSP) or once-monthly ibandronic acid with bone turnover marker monitoring (BM).
Secondary outcome measures	To ascertain reasons for discontinuation from treatment.
Overall study start date	06/06/2005
Completion date	28/02/2006

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	600
Key inclusion criteria	1. Women with postmenopausal osteoporosis diagnosed according to the clinical judgment 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 bisphosphonate 2. Patients who have had a fracture(s) in the past 6 months 3. Patients who have been on hormone replacement therapy (HRT) in the past 6 months 4. Patients who are unlikely to complete the entire 6-month study period due to significant medical condition 5. Patients with an inability to stand or sit upright for at least 60 minutes 6. Patients with abnormalities of the oesophagus that delay oesophageal emptying, such as achalasia and stricture 7. Patients with hypersensitivity to bisphosphonates 8. Administration of any investigational drug within 30 days preceding the first dose of the study drug 9. Patients with galactose intolerance
Date of first enrolment	06/06/2005
Date of final enrolment	28/02/2006

Roche Products Ltd

Welwyn Garden City
AL7 3AY
United Kingdom

Roche Products Ltd (UK)
Industry

Hexagon Place
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Industry

Roche Products Ltd (UK)

No information available

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