Condition category
Musculoskeletal Diseases
Date applied
13/06/2005
Date assigned
15/08/2005
Last edited
31/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Patricia Campbell

ORCID ID

Contact details

Roche Products Ltd
40 Broadwater road
Welwyn Garden City
AL7 3AY
United Kingdom
+44 (0)1707 367862

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ML 18373

Study information

Scientific title

Acronym

Back up study

Study hypothesis

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

Not provided at time of registration

Study design

Multicentre randomised open label controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

06/06/2005

Overall trial end date

28/02/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

600

Participant 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

Recruitment start date

06/06/2005

Recruitment end date

28/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Roche Products Ltd
Welwyn Garden City
AL7 3AY
United Kingdom

Sponsor information

Organisation

Roche Products Ltd (UK)

Sponsor details

Hexagon Place
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
+44 (0)1707 366 835
vicky.diment@roche.com

Sponsor type

Industry

Website

http://www.roche.com

Funders

Funder type

Industry

Funder name

Roche Products Ltd (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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes