NCT00453492

Brief Summary

The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women. The secondary objectives are to measure compliance (50 % drug taken), and persistence, \[and urinary NTx (N-telopeptides) (optional)\].

Trial Health

80
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
Last Updated

March 11, 2008

Status Verified

March 1, 2008

First QC Date

March 28, 2007

Last Update Submit

March 10, 2008

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (2)

  • Measurement of subject satisfaction using a questionnaire at 12 and 24 weeks and a tablets counts at 12 and 24 weeks.

  • Optional: the effects of Actonel on bone resorption will be assessed by a change of urinary NTx, after 12 and 24 weeks of treatment as compared to baseline.

Interventions

risedronate sodiumDRUG

Eligibility Criteria

Age55 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Five years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
  • Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (≥ 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Actonel.
  • Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication, they may be given at the discretion of the Investigator.

You may not qualify if:

  • Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

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

  • Edibe Taylan

    Sanofi-aventis, Turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 29, 2007

Study Start

January 1, 2004

Last Updated

March 11, 2008

Record last verified: 2008-03

Locations

TU(1)