Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00577421




Registration number
NCT00577421
Ethics application status
Date submitted
19/12/2007
Date registered
20/12/2007
Date last updated
28/09/2011

Titles & IDs
Public title
Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO
Scientific title
An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO
Secondary ID [1] 0 0
2002157
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - risedronate

Experimental: 1 - 5 mg/day risedronate


Treatment: Drugs: risedronate
5 mg tablet of risedronate once a day for 2 years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety and tolerability profile of 5 mg daily oral risedronate therapy administered for 2 years in patients with post-menopausal osteoporosis, who had received risedronate for 2 or 7 years and then had a risedronate-free year.
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
* have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study)
Minimum age
55 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Can not use any bone modifying substances except risedronate

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2006
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Concord
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Sienna
Country [2] 0 0
Poland
State/province [2] 0 0
Warsaw
Country [3] 0 0
Spain
State/province [3] 0 0
Barcelona
Country [4] 0 0
Sweden
State/province [4] 0 0
Goteborg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Warner Chilcott
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)
Trial website
https://clinicaltrials.gov/study/NCT00577421
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dietrich H Wenderoth, MD
Address 0 0
Procter and Gamble
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00577421