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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00619957




Registration number
NCT00619957
Ethics application status
Date submitted
11/02/2008
Date registered
21/02/2008
Date last updated
28/10/2011

Titles & IDs
Public title
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
Scientific title
Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study
Secondary ID [1] 0 0
2001092 and 2001092 OL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Other 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 - Placebo tablet
Treatment: Drugs - Risedronate

Placebo Comparator: 1 - Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years

Experimental: Risedronate - 35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years


Treatment: Drugs: Placebo tablet
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years

Treatment: Drugs: Risedronate
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
Timepoint [1] 0 0
Baseline to 24 Months/Endpoint
Secondary outcome [1] 0 0
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
Timepoint [1] 0 0
Baseline to Month 6
Secondary outcome [2] 0 0
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
Timepoint [2] 0 0
Baseline to Month 12
Secondary outcome [3] 0 0
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
Timepoint [3] 0 0
Baseline to Month 24
Secondary outcome [4] 0 0
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
Timepoint [4] 0 0
Baseline to Month 6
Secondary outcome [5] 0 0
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
Timepoint [5] 0 0
Baseline to Month 12
Secondary outcome [6] 0 0
Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
Timepoint [6] 0 0
Baseline to Month 24
Secondary outcome [7] 0 0
Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
Timepoint [7] 0 0
Baseline to 24 Months/Endpoint
Secondary outcome [8] 0 0
Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
Timepoint [8] 0 0
Baseline to Month 6
Secondary outcome [9] 0 0
Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
Timepoint [9] 0 0
Baseline to Month 12
Secondary outcome [10] 0 0
Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
Timepoint [10] 0 0
Baseline to Month 24
Secondary outcome [11] 0 0
Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
Timepoint [11] 0 0
Baseline to 24 Months/Endpoint
Secondary outcome [12] 0 0
Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
Timepoint [12] 0 0
Baseline to Month 6
Secondary outcome [13] 0 0
Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
Timepoint [13] 0 0
Baseline to Month 12
Secondary outcome [14] 0 0
Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
Timepoint [14] 0 0
Baseline to Month 24
Secondary outcome [15] 0 0
Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
Timepoint [15] 0 0
Baseline to 24 Months/Endpoint
Secondary outcome [16] 0 0
Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
Timepoint [16] 0 0
Baseline to Month 3
Secondary outcome [17] 0 0
Percent Change From Baseline in CTx, Month 6, ITT Population.
Timepoint [17] 0 0
Baseline to Month 6
Secondary outcome [18] 0 0
Percent Change From Baseline in CTx, Month 12, ITT Population.
Timepoint [18] 0 0
Baseline to Month 12
Secondary outcome [19] 0 0
Percent Change From Baseline in CTx, Month 24, ITT Population.
Timepoint [19] 0 0
Baseline to Month 24
Secondary outcome [20] 0 0
Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
Timepoint [20] 0 0
Baseline to 24 Months/Endpoint
Secondary outcome [21] 0 0
Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
Timepoint [21] 0 0
Baseline to Month 3
Secondary outcome [22] 0 0
Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
Timepoint [22] 0 0
Baseline to Month 6
Secondary outcome [23] 0 0
Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
Timepoint [23] 0 0
Baseline to Month 12
Secondary outcome [24] 0 0
Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
Timepoint [24] 0 0
Baseline to Month 24
Secondary outcome [25] 0 0
Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
Timepoint [25] 0 0
Baseline to 24 Months/Endpoint
Secondary outcome [26] 0 0
Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
Timepoint [26] 0 0
Baseline to Month 3
Secondary outcome [27] 0 0
Percent Change From Baseline in BAP, Month 6, ITT Population.
Timepoint [27] 0 0
Baseline to Month 6
Secondary outcome [28] 0 0
Percent Change From Baseline in BAP, Month 12, ITT Population.
Timepoint [28] 0 0
Baseline to Month 12
Secondary outcome [29] 0 0
Percent Change From Baseline in BAP, Month 24, ITT Population.
Timepoint [29] 0 0
Baseline to Month 24
Secondary outcome [30] 0 0
Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
Timepoint [30] 0 0
Baseline to 24 Months/Endpoint
Secondary outcome [31] 0 0
Change From Baseline in Body Height, Month 12, ITT Population.
Timepoint [31] 0 0
Baseline to Month 12
Secondary outcome [32] 0 0
Change From Baseline in Body Height, Month 24, ITT Population.
Timepoint [32] 0 0
Baseline to Month 24
Secondary outcome [33] 0 0
Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
Timepoint [33] 0 0
Baseline to 24 Months/Endpoint
Secondary outcome [34] 0 0
Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
Timepoint [34] 0 0
Baseline to Month 24
Secondary outcome [35] 0 0
Cumulative Incidence of Fractures, 12 Months, ITT Population
Timepoint [35] 0 0
Baseline to Month 12
Secondary outcome [36] 0 0
Cumulative Incidence of Fractures, 24 Months, ITT Population
Timepoint [36] 0 0
Baseline to Month 24

Eligibility
Key inclusion criteria
- Documented osteoporosis of the femoral neck and lumbar spine
Minimum age
30 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- BMI greater than or equal to 35

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
1/06/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
285
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Facility - Concord
Recruitment hospital [2] 0 0
Research Facility - Heidelburg
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Heidelburg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Prague
Country [10] 0 0
France
State/province [10] 0 0
Angers
Country [11] 0 0
France
State/province [11] 0 0
Lyon
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Lebanon
State/province [13] 0 0
Beirut
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam
Country [15] 0 0
Poland
State/province [15] 0 0
Bialystok
Country [16] 0 0
Poland
State/province [16] 0 0
Warsaw
Country [17] 0 0
Poland
State/province [17] 0 0
Wroclaw
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Newcastle
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Sheffield

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
Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men
with osteoporosis followed by a two year follow-up study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00619957
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dietrich 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/ct2/show/NCT00619957