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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01249261




Registration number
NCT01249261
Ethics application status
Date submitted
24/11/2010
Date registered
29/11/2010
Date last updated
2/11/2011

Titles & IDs
Public title
Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover
Scientific title
A 1-year, Risedronate-free, Multicenter, Outpatient, Phase IIIb Extension Study to Assess Bone Turnover Recovery in Women With Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, and RVE1998080 (no NCT Study Numbers)
Secondary ID [1] 0 0
2001079
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Women With Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

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

Placebo comparator: Placebo/Risedronate - Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8

Active comparator: Risedronate - Risedronate 5mg years 1-7, no drug year 8


Treatment: Drugs: Risedronate
5 mg/day

Treatment: Drugs: Placebo/Risedronate
placebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
Timepoint [1] 0 0
Baseline Core Study (Year 1) to Month 6 (Year 8)
Primary outcome [2] 0 0
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
Timepoint [2] 0 0
Baseline Core Study (Year 1) to Month 12 (Year 8)
Primary outcome [3] 0 0
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Timepoint [3] 0 0
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Primary outcome [4] 0 0
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
Timepoint [4] 0 0
Baseline Core Study (Year 1) to Month 6 (Year 8)
Primary outcome [5] 0 0
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
Timepoint [5] 0 0
Baseline Core Study (Year 1) to Month 12 (Year 8)
Primary outcome [6] 0 0
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Timepoint [6] 0 0
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Primary outcome [7] 0 0
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
Timepoint [7] 0 0
Baseline Core Study (Year 1) to Month 6 (Year 8)
Primary outcome [8] 0 0
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
Timepoint [8] 0 0
Baseline Core Study (Year 1) to Month 12 (Year 8)
Primary outcome [9] 0 0
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Timepoint [9] 0 0
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Primary outcome [10] 0 0
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
Timepoint [10] 0 0
Baseline Core Study (Year 1) to Month 6 (Year 8)
Primary outcome [11] 0 0
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
Timepoint [11] 0 0
Baseline Core Study (Year 1) to Month 12 (Year 8)
Primary outcome [12] 0 0
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Timepoint [12] 0 0
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

Eligibility
Key inclusion criteria
* Post-menopausal women who sequentially completed studies RVE009093, RVE1996077, RVE1998080
Minimum age
No limit
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Less than 60% compliant between drug start and month 21
* Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection >10,000 IU vitamin D, investigational drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
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
1/10/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2003
Sample size
Target
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Investigational Site - Concord
Recruitment hospital [2] 0 0
Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Gent
Country [2] 0 0
Denmark
State/province [2] 0 0
Hvidovre
Country [3] 0 0
Finland
State/province [3] 0 0
Oulu
Country [4] 0 0
Italy
State/province [4] 0 0
Siena
Country [5] 0 0
Poland
State/province [5] 0 0
Warsaw
Country [6] 0 0
Poland
State/province [6] 0 0
Warszawa
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid
Country [9] 0 0
Sweden
State/province [9] 0 0
Goteborg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Warner Chilcott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Herman Ellman, MD
Address 0 0
Warner Chilcott
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01249261