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Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

Primary Purpose

Osteoporosis, Postmenopausal

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

risedronate (HMR4003)

About this trial

This is an interventional prevention trial for Osteoporosis, Postmenopausal focused on measuring Prevention of postmenopausal osteoporosis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Sanofi-Aventis
Sanofi-Aventis
Sanofi-Aventis
Sanofi-Aventis
Sanofi-Aventis

Outcomes

Primary Outcome Measures

Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.

Secondary Outcome Measures

Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)

Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24

Percent changes in bone turnover markers after 12 and 24 months of treatment

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

Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events

Full Information

NCT ID

NCT00353080

First Posted

July 13, 2006

Last Updated

December 11, 2009

Sponsor

Sanofi

Collaborators

Procter and Gamble

1. Study Identification

Unique Protocol Identification Number

NCT00353080

Brief Title

Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

April 2005 (Actual)

Study Completion Date

April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

Collaborators

Procter and Gamble

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Postmenopausal

Keywords

Prevention of postmenopausal osteoporosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

171 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

risedronate (HMR4003)

Primary Outcome Measure Information:

Title

Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.

Secondary Outcome Measure Information:

Title

Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)

Title

Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24

Title

Percent changes in bone turnover markers after 12 and 24 months of treatment

Title

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

Title

Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Välimäki Matti, MD

Organizational Affiliation

Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanofi-Aventis

City

Helsinki

Country

Finland

Facility Name

Sanofi-Aventis

City

Gouda

Country

Netherlands

Facility Name

Sanofi-Aventis

City

Oslo

Country

Norway

Facility Name

Sanofi-Aventis

City

Madrid

Country

Spain

Facility Name

Sanofi-Aventis

City

Stockholm

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

18035193

Citation

Valimaki MJ, Farrerons-Minguella J, Halse J, Kroger H, Maroni M, Mulder H, Munoz-Torres M, Saaf M, Snorre Ofjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49. doi: 10.1016/j.clinthera.2007.09.017.

Results Reference

result

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Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

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