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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00247273




Registration number
NCT00247273
Ethics application status
Date submitted
28/10/2005
Date registered
1/11/2005
Date last updated
22/04/2013

Titles & IDs
Public title
A Study of Monthly Risedronate for Osteoporosis
Scientific title
A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
Secondary ID [1] 0 0
EFC6062 AND HMRF004M/3001
Secondary ID [2] 0 0
2005032
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

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

Active comparator: 1 - 5 mg risedronate, once daily for 2 years

Experimental: 2 - 150 mg risedronate taken once a month for 2 years


Treatment: Drugs: risedronate
tablet, 5 mg risedronate, once a day for 2 years

Treatment: Drugs: risedronate
oral, 150 mg risedronate, once a month for 2 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) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
Timepoint [1] 0 0
Baseline to Month 12 - Endpoint
Secondary outcome [1] 0 0
Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
Timepoint [1] 0 0
Baseline to Month 12
Secondary outcome [2] 0 0
Change From Baseline in Lumbar Spine BMD at 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 at Month 24-Endpoint, Endpoint Population (Month 24)
Timepoint [3] 0 0
Baseline to Month 24 - Endpoint
Secondary outcome [4] 0 0
Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Timepoint [4] 0 0
Baseline to Month 24
Secondary outcome [5] 0 0
Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Timepoint [5] 0 0
Baseline to Month 24
Secondary outcome [6] 0 0
Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
Timepoint [6] 0 0
Baseline to Month 6
Secondary outcome [7] 0 0
Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
Timepoint [7] 0 0
Baseline to Month 6
Secondary outcome [8] 0 0
Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Timepoint [8] 0 0
Baseline to Month 24
Secondary outcome [9] 0 0
Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Timepoint [9] 0 0
Baseline to Month 24
Secondary outcome [10] 0 0
Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
Timepoint [10] 0 0
Baseline to Month 6
Secondary outcome [11] 0 0
Percent Change From Baseline in Serum CTX at Month 6, ITT Population
Timepoint [11] 0 0
Baseline to Month 6
Secondary outcome [12] 0 0
Change From Baseline in Serum CTX at Month 24, ITT Population
Timepoint [12] 0 0
Baseline to Month 24
Secondary outcome [13] 0 0
Percent Change From Baseline in Serum CTX at Month 24, ITT Population
Timepoint [13] 0 0
Baseline to Month 24
Secondary outcome [14] 0 0
Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
Timepoint [14] 0 0
Baseline to Month 6
Secondary outcome [15] 0 0
Percent Change From Baseline in Serum BAP at Month 6, ITT Population
Timepoint [15] 0 0
Baseline to Month 6
Secondary outcome [16] 0 0
Change From Baseline in Serum BAP at Month 24, ITT Population
Timepoint [16] 0 0
Baseline to Month 24
Secondary outcome [17] 0 0
Percent Change From Baseline in Serum BAP at Month 24, ITT Population
Timepoint [17] 0 0
Baseline to Month 24
Secondary outcome [18] 0 0
Number of Participants With New Vertebral Fracture at Month 12, ITT Population
Timepoint [18] 0 0
Baseline to Month 12
Secondary outcome [19] 0 0
Number of Participants With New Vertebral Fracture at Month 24, ITT Population
Timepoint [19] 0 0
Baseline to Month 24

Eligibility
Key inclusion criteria
* Female: 50 years of age or older
* >5 years since last menses natural or surgical
* have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
* BMI (body mass index) >32 kg/m^2
* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
* hypocalcemia or hypercalcemia of any cause
* markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

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
1/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
1294
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Geelong
Recruitment hospital [2] 0 0
Research Site - Heidelberg, Victoria
Recruitment hospital [3] 0 0
Research Site - Saint Leonards
Recruitment postcode(s) [1] 0 0
- Geelong
Recruitment postcode(s) [2] 0 0
- Heidelberg, Victoria
Recruitment postcode(s) [3] 0 0
- Saint Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Capital Federal
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussels
Country [11] 0 0
Belgium
State/province [11] 0 0
Gent
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liege
Country [14] 0 0
Belgium
State/province [14] 0 0
Mont Godinne
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio de Janeiro
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
Calgary
Country [18] 0 0
Canada
State/province [18] 0 0
Montreal
Country [19] 0 0
Canada
State/province [19] 0 0
Sainte Foy
Country [20] 0 0
Canada
State/province [20] 0 0
Saskatoon
Country [21] 0 0
Estonia
State/province [21] 0 0
Parnu
Country [22] 0 0
Estonia
State/province [22] 0 0
Tartu
Country [23] 0 0
Finland
State/province [23] 0 0
Helsinki
Country [24] 0 0
Finland
State/province [24] 0 0
Kuopio
Country [25] 0 0
Finland
State/province [25] 0 0
Oulu
Country [26] 0 0
Finland
State/province [26] 0 0
Turku
Country [27] 0 0
France
State/province [27] 0 0
Amiens Cedex 1
Country [28] 0 0
France
State/province [28] 0 0
Lyon Cedex
Country [29] 0 0
France
State/province [29] 0 0
Orleans
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Toulouse
Country [32] 0 0
France
State/province [32] 0 0
Vandoeuvre Les Nancy
Country [33] 0 0
Hungary
State/province [33] 0 0
Balatonfured
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Gyor
Country [36] 0 0
Hungary
State/province [36] 0 0
Miskolc
Country [37] 0 0
Hungary
State/province [37] 0 0
Nagykanizs
Country [38] 0 0
Lebanon
State/province [38] 0 0
Beirut
Country [39] 0 0
Norway
State/province [39] 0 0
Oslo
Country [40] 0 0
Norway
State/province [40] 0 0
Paradis
Country [41] 0 0
Norway
State/province [41] 0 0
Trondheim
Country [42] 0 0
Poland
State/province [42] 0 0
Bialystok
Country [43] 0 0
Poland
State/province [43] 0 0
Warszawa
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Granada
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid

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
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Trial website
https://clinicaltrials.gov/study/NCT00247273
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sal Bartelmo, MD
Address 0 0
P&G
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/study/NCT00247273