Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
Query!
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)
Query!
Secondary ID [1]
0
0
2001079
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Women With Osteoporosis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoporosis
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Baseline Core Study (Year 1) to Month 6 (Year 8)
Query!
Primary outcome [2]
0
0
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Baseline Core Study (Year 1) to Month 12 (Year 8)
Query!
Primary outcome [3]
0
0
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Query!
Assessment method [3]
0
0
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).
Query!
Timepoint [3]
0
0
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Query!
Primary outcome [4]
0
0
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
Query!
Assessment method [4]
0
0
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).
Query!
Timepoint [4]
0
0
Baseline Core Study (Year 1) to Month 6 (Year 8)
Query!
Primary outcome [5]
0
0
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
Query!
Assessment method [5]
0
0
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).
Query!
Timepoint [5]
0
0
Baseline Core Study (Year 1) to Month 12 (Year 8)
Query!
Primary outcome [6]
0
0
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Query!
Assessment method [6]
0
0
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).
Query!
Timepoint [6]
0
0
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Query!
Primary outcome [7]
0
0
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
Query!
Assessment method [7]
0
0
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).
Query!
Timepoint [7]
0
0
Baseline Core Study (Year 1) to Month 6 (Year 8)
Query!
Primary outcome [8]
0
0
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
Query!
Assessment method [8]
0
0
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).
Query!
Timepoint [8]
0
0
Baseline Core Study (Year 1) to Month 12 (Year 8)
Query!
Primary outcome [9]
0
0
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Query!
Assessment method [9]
0
0
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).
Query!
Timepoint [9]
0
0
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Query!
Primary outcome [10]
0
0
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
Query!
Assessment method [10]
0
0
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).
Query!
Timepoint [10]
0
0
Baseline Core Study (Year 1) to Month 6 (Year 8)
Query!
Primary outcome [11]
0
0
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
Query!
Assessment method [11]
0
0
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).
Query!
Timepoint [11]
0
0
Baseline Core Study (Year 1) to Month 12 (Year 8)
Query!
Primary outcome [12]
0
0
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
Query!
Assessment method [12]
0
0
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).
Query!
Timepoint [12]
0
0
Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Query!
Eligibility
Key inclusion criteria
- Post-menopausal women who sequentially completed studies RVE009093, RVE1996077,
RVE1998080
Query!
Minimum age
No limit
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2001
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/05/2003
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
61
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Investigational Site - Concord
Query!
Recruitment hospital [2]
0
0
Investigational Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [2]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Gent
Query!
Country [2]
0
0
Denmark
Query!
State/province [2]
0
0
Hvidovre
Query!
Country [3]
0
0
Finland
Query!
State/province [3]
0
0
Oulu
Query!
Country [4]
0
0
Italy
Query!
State/province [4]
0
0
Siena
Query!
Country [5]
0
0
Poland
Query!
State/province [5]
0
0
Warsaw
Query!
Country [6]
0
0
Poland
Query!
State/province [6]
0
0
Warszawa
Query!
Country [7]
0
0
Spain
Query!
State/province [7]
0
0
Barcelona
Query!
Country [8]
0
0
Spain
Query!
State/province [8]
0
0
Madrid
Query!
Country [9]
0
0
Sweden
Query!
State/province [9]
0
0
Goteborg
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Warner Chilcott
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01249261
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Herman Ellman, MD
Query!
Address
0
0
Warner Chilcott
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01249261
Download to PDF