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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/NCT00358176




Registration number
NCT00358176
Ethics application status
Date submitted
28/07/2006
Date registered
31/07/2006
Date last updated
15/12/2009

Titles & IDs
Public title
Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women
Scientific title
A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.
Secondary ID [1] 0 0
HMR4003M/3001
Secondary ID [2] 0 0
EFC6063
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis Postmenopausal 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 (HMR4003)

Treatment: Drugs: Risedronate (HMR4003)
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
Timepoint [1] 0 0
Primary outcome [2] 0 0
Month 12 measured by dual-energy X-ray absorptiometry (DXA).
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Safety: AEs, clinical laboratory values, bone biopsies.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Physical examination before treatment and after 12 and 24 months of treatment.
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
Subjects meeting all of the following criteria were considered for enrollment into the
study :

·Ambulatory, healthy postmenopausal women with :

- Natural menopause and more than 5 years after their last menstrual period.

- Or surgical menopause and more than 5 years after surgery (blood hormone tests
required for subjects less than 65 years of age who had uterus removed without removal
of ovaries at time of surgery).

Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young
women or more than 2.0 SD below the mean value in normal young women and at least 1
fracture of a vertebra (thoracic-lumbar T4-L4)).
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with any of the following criteria were not considered for enrollment into the
study :

·Women who have received hormone replacement therapy (with estrogen by mouth and/or
progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin,
calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3
months before first dose of study medication.

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
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
1231
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
San Isidro
Country [3] 0 0
Canada
State/province [3] 0 0
Laval
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Prague
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Lebanon
State/province [6] 0 0
Beirut
Country [7] 0 0
Poland
State/province [7] 0 0
Warszawa
Country [8] 0 0
South Africa
State/province [8] 0 0
Midrand
Country [9] 0 0
Turkey
State/province [9] 0 0
Istanbul
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Procter and Gamble
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per
month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar
spine in postmenopausal women with osteoporosis.

To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in
postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral
neck and femoral trochanter and decreasing bone resorption.

To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month
as compared to 5 mg risedronate taken daily.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00358176
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
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/NCT00358176