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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).
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 - Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).
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 - Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).
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 - Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
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 - Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
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 - Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
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 - Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
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 - Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
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 - Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
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 - Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
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 - Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
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 - Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
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
Gender
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
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)
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
The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on
BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.
Trial website
https://clinicaltrials.gov/show/NCT01249261
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

Summary results
Other publications