NCT00353080

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2002

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

2.3 years

First QC Date

July 13, 2006

Last Update Submit

December 11, 2009

Conditions

Osteoporosis, Postmenopausal

Keywords

Prevention of postmenopausal osteoporosis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

risedronate (HMR4003)DRUG

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sanofi-Aventis

Helsinki, Finland

Location

Sanofi-Aventis

Gouda, Netherlands

Location

Sanofi-Aventis

Oslo, Norway

Location

Sanofi-Aventis

Madrid, Spain

Location

Sanofi-Aventis

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 18035193RESULT

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Välimäki Matti, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 17, 2006

Study Start

December 1, 2002

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

NL(1)ES(1)NO(1)SE(1)FI(1)