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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Other publications