Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

Osteoporosis Postmenopausal Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358176
• Other study ID #: EFC6063
• Secondary ID: HMR4003M/3001
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2006
• Last updated: December 11, 2009
• Start date: July 2004
• Est. completion date: March 2007

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaSouth Africa: Medicines Control CouncilFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1231
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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)).

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Postmenopausal
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Risedronate (HMR4003)

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	San Isidro
Australia	Sanofi-Aventis	Macquarie Park
Canada	Sanofi-Aventis	Laval
Czech Republic	Sanofi-Aventis	Prague
France	Sanofi-Aventis	Paris
Lebanon	Sanofi-Aventis	Beirut
Poland	Sanofi-Aventis	Warszawa
South Africa	Sanofi-Aventis	Midrand
Turkey	Sanofi-Aventis	Istanbul
United Kingdom	Sanofi-Aventis	Guildford Surrey
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Czech Republic,  France,  Lebanon,  Poland,  South Africa,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in lumbar spine bone mineral density (BMD) at
Primary	Month 12 measured by dual-energy X-ray absorptiometry (DXA).
Secondary	Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.
Secondary	Safety: AEs, clinical laboratory values, bone biopsies.
Secondary	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.
Secondary	Physical examination before treatment and after 12 and 24 months of treatment.