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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
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. - DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
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 - responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24
Timepoint [34] 0 0
Baseline to Month 24
Secondary outcome [35] 0 0
Cumulative Incidence of Fractures, 12 Months, ITT Population - Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
Timepoint [35] 0 0
Baseline to Month 12
Secondary outcome [36] 0 0
Cumulative Incidence of Fractures, 24 Months, ITT Population - Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years
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
Gender
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
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 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/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
Other publications