NCT00358176

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 Health

98
On Track

Trial Health Score

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

Enrollment
1,231

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2004

Typical duration for phase_3

Geographic Reach
11 countries

11 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

July 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

2.7 years

First QC Date

July 28, 2006

Last Update Submit

December 11, 2009

Conditions

Osteoporosis Postmenopausal

Keywords

Treatment osteoporosis postmenopausal

Outcome Measures

Primary Outcomes (2)

  • Percent change from baseline in lumbar spine bone mineral density (BMD) at

  • Month 12 measured by dual-energy X-ray absorptiometry (DXA).

Secondary Outcomes (4)

  • Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.

  • Safety: AEs, clinical laboratory values, bone biopsies.

  • 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.

  • Physical examination before treatment and after 12 and 24 months of treatment.

Interventions

Risedronate (HMR4003)DRUG

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

San Isidro, Argentina

Location

Sanofi-Aventis

Macquarie Park, Australia

Location

Sanofi-Aventis

Laval, Canada

Location

Sanofi-Aventis

Prague, Czechia

Location

Sanofi-Aventis

Paris, France

Location

Sanofi-Aventis

Beirut, Lebanon

Location

Sanofi-Aventis

Warsaw, Poland

Location

Sanofi-Aventis

Midrand, South Africa

Location

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

Sanofi-Aventis

Guildford Surrey, United Kingdom

Location

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

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 28, 2006

First Posted

July 31, 2006

Study Start

July 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

TU(1)GB(1)CZ(1)LE(1)ZA(1)AU(1)FR(1)US(1)PL(1)CA(1)AR(1)