Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

Osteoporosis, Postmenopausal Clinical Trial

Official title:

A Two-year, Multicenter, Double-blind, Randomized, Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353080
• Other study ID #: EFC6064
• Secondary ID: HMR4003B/3001
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2006
• Last updated: December 11, 2009
• Start date: December 2002
• Est. completion date: April 2005

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women

To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption

To confirm general safety of 5 mg daily risedronate as compared to placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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

• osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).

• With at least one risk factor for osteoporosis

Exclusion Criteria:

• Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• risedronate (HMR4003)

Locations

Country	Name	City	State
Finland	Sanofi-Aventis	Helsinki
Netherlands	Sanofi-Aventis	Gouda
Norway	Sanofi-Aventis	Oslo
Spain	Sanofi-Aventis	Madrid
Sweden	Sanofi-Aventis	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

Countries where clinical trial is conducted

Finland,  Netherlands,  Norway,  Spain,  Sweden, 

References & Publications (1)

Välimäki MJ, Farrerons-Minguella J, Halse J, Kröger H, Maroni M, Mulder H, Muñoz-Torres M, Sääf M, Snorre Øfjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multination — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.
Secondary	Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)
Secondary	Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24
Secondary	Percent changes in bone turnover markers after 12 and 24 months of treatment
Secondary	Physical examination and hematology tests before and after 12 and 24 months of treatment;Serum Chemistry before and after 6, 12 and 24 months of treatment
Secondary	Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events